Euro OTC News No. 225 8 August 2011

Euro OTC News
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No. 225
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8 August 2011
MEDICINES NEWS ................................................................... 2 European Commission reconfirms that national procedure remains available for nonharmonised products ................................................................................................................. 2 News from the Agency and its Committees .................................................................................. 2 • Version 8 of QRD Template: No text on product-related web addresses ....................................... 2 • CHMP rejects centralised switch of sumatriptan for migraine attacks ........................................... 3 • EMA reports on Benefit-risk methodology project......................................................................... 4 • New EMA Publications ................................................................................................................... 4 AESGP consulted .......................................................................................................................... 5 AESGP submits comments on Revision of Chapter 8 - GMP Guide ............................................ 6 Commission summarises responses on revision of Clinical Trials Directive ............................... 7 Herbal news ................................................................................................................................... 9 • HMPC adopts six new monographs as final ................................................................................... 9 • AESGP consulted .......................................................................................................................... 10 • Other HMPC publications ............................................................................................................. 11 • PhVWP warns on allergic reactions after exposure to Ispaghula seeds ........................................ 11 FOOD NEWS .......................................................................... 13 Health claims ............................................................................................................................... 13 • EFSA publishes sixth and final series of Article 13 health claim opinions .................................. 13 New EFSA Opinions ................................................................................................................... 14 • Opinions on three Article 13(5) and two Article 14 health claims… ........................................... 14 • …and on a novel food ingredient .................................................................................................. 16 COUNTRY NEWS ................................................................... 17 Germany ...................................................................................................................................... 17 • Switches and reverse switches ...................................................................................................... 17 • Self-medication budget being discussed ....................................................................................... 17 • BAH continues promotion of the ‘Green Prescription’ form ........................................................ 17 Spain ............................................................................................................................................ 18 • New Guideline on Invented Names should increase certainty for manufacturers of nonprescription medicines................................................................................................................... 18 United Kingdom .......................................................................................................................... 19 • PAGB Advertising Codes now online .......................................................................................... 19 Change of date!
AESGP Workshop with the EU Heads of Medicines Agencies
Copenhagen ™ Denmark
Now: 21-22 February 2012
The Association of the European Self-Medication Industry (AESGP)
7, avenue de Tervuren • B-1040 Brussels • Belgium • Tel.: + 32 (0)2 735 51 30 • Fax: + 32 (0)2 735 52 22
E-mail: [email protected] • http://www.aesgp.be
MEDICINES NEWS
EUROPEAN COMMISSION RECONFIRMS THAT NATIONAL PROCEDURE REMAINS
AVAILABLE FOR NON-HARMONISED PRODUCTS
Some national
bibliographic applications recently rejected….
In preparation of the upcoming AESGP conference 1 in London on 18-19 October 2011, AESGP discussed some problems with regard to the use of the
national marketing authorisation procedure with the Pharmaceutical Unit of
the European Commission. In fact, some cases had been brought to AESGP’s
attention in which applications for national bibliographic procedures were
rejected by the National Competent Authorities on the basis that a mutual
recognition procedure or a decentralised procedure (depending on the case)
should have been applied for instead.
…but 1998 Commission remains
valid…
However, the Commission confirmed the validity of its Communication on
the Community marketing authorisation procedures for medicinal products of
1998 (98/ C 229/ 03) 2 which clearly states in section 5 that “[….] in the case
of a medicinal product with a well-established use demonstrated in accordance with Article 4(3)(8)(a)(ii) of Directive 65/65/EEC (“bibliographical
application’), this well-established use being based on data referring to an existing group of products with different SPCs in the Member States, national
independent procedures could continue to be followed as far as no Community harmonisation of the use of the constituent(s) of the said product exists;
the purposes of Article 7a of Directive 75/319/EEC being not to provide harmonisation of an entire therapeutic class or a complete group of products.”
…for nonharmonised products
In virtue of this Commission Communication, parallel national procedures for
bibliographic applications of well-established medicines which the SPC has
not been harmonised therefore remain possible. The AESGP conference in
October will provide the occasion to debate this point further with Commission and Member State representatives.
NEWS FROM THE AGENCY AND ITS COMMITTEES
Version 8 of QRD Template: No text on product-related web addresses
Publication delayed due to some
outstanding issues
The EMA has now published Version 8 3 of the Quality Review of Documents
(QRD) human product-information template. Other language versions are
available from this webpage 4 . As reported in AESGP Euro OTC News No
222, p. 10, the publication of the new QRD template was delayed on account
of some outstanding issues which needed to be re-discussed in the QRD plenary meeting, for instance the inclusion of product-related website address on
the label in the leaflet of non-prescription medicines.
1
http://www.aesgp.be/London2011/London2011Programme.pdf
http://ec.europa.eu/health/files/eudralex/vol-1/com_1998/com_1998_en.pdf
3
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500004369
4
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&murl
=menus/regulations/regulations.jsp&mid=WC0b01ac0580022c59
2
AESGP Euro OTC News No. 225
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No guidance on
product-related
web addresses…
The final Version 8 of the template nevertheless remains silent on this point
(the corresponding sentence in the draft version has been deleted in the final
version). Isabelle MOULON, the Head of the Medical Information Sector,
explains in a letter that “this decision has been taken following extensive discussions.”
…but Commission
sees no objections
“However, the European Commission re-confirmed that it cannot be prohibited, as a matter of principle, to include an internet address of an OTC specific website in the PIL provided the requirements of Article 62 of Directive
2001/83/EC are fulfilled. Therefore the inclusion of a product website address is in principle acceptable for OTC products as the information could be
considered useful for patients in a self-medication situation.”
Product information to be
brought in line at
time of first regulatory procedure
The Agency has also published an implementation plan 1 which states that
“for existing marketing authorisations granted via the centralised procedure,
applicants are encouraged to use the first upcoming regulatory procedure affecting Product Information Annexes (e.g. Line Extension, Variation II, etc.)
to comply with the revised QRD template, or at the latest on the occasion of
the five-yearly renewal of the marketing authorisation.
For products with no regulatory activity, marketing authorisation holders are
advised to update their Product Information Annexes according to Version 8
within three years from publication of the QRD template. On a case-by-case
basis, further extension may be considered. Article 61(3) notifications, all
Type IA Variations and Type IB Variations not affecting the Product Information Annexes should not be used for this purpose.”
CHMP rejects centralised switch of sumatriptan for migraine attacks
Because “lack of
medical supervision and monitoring would increase risk of
brain and heart
side effects”
At its 18-21 July meeting 2 , the Committee for Medicinal Products for Human
Use (CHMP) adopted by majority a negative opinion recommending that no
marketing authorisation should be granted for Sumatriptan Galpharm (sumatriptan), from Galpharm Healthcare Ltd. Sumatriptan Galpharm (50 mg tablets) was intended as a non-prescription medicine for the relief of migraine
attacks in patients who had been diagnosed with migraine. Sumatriptan is a
generic of Imigran®.
A separate question-and-answer document 3 states that “the CHMP considered
that Sumatriptan Galpharm in the non-prescription setting was not approvable
because lack of medical supervision and monitoring of the patient would increase the risk of cerebrovascular (brain) and cardiovascular (heart) side effects and potential misuse. The CHMP felt that Sumatriptan Galpharm in the
non-prescription setting was not appropriate because migraine as a condition
changes over time as does patients’ cardiovascular and cerebrovascular status,
and that monitoring is therefore essential. It felt that the measures proposed
by the company to reduce these risks were insufficient.”
1
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC5000047
04.pdf
2
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109673
3
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002140/smops/Negative/human_sm
op_000253.jsp&mid=WC0b01ac058001d127&murl=menus/medicines/medicines.jsp
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EMA reports on Benefit-risk methodology project
Aim is to identify
decision-making
models
In early 2009 the European Medicines Agency began a three-year project on
benefit-risk methodology 1 which aims to identify decision-making models
that can be used in the Agency’s work to make the assessment of the benefits
and risks of medicines more consistent, more transparent and easier to audit.
The project 2 , which began on the recommendation of a CHMP working group
which met between 2006 and 2008 and produced conclusions in early 2008,
consists of the following five ‘work packages’:
Report of WP1:
“Benefit-risk balance is most difficult part of assessment process
Work package
Status
1. Describing the benefit-risk assessment models already
being used in the European Union’s regulatory network
Completed
March 2010
2. Assessing the suitability of the current tools and processes used in benefit-risk assessments
Completed
August 2010
3. Field-testing the most appropriate models in five European medicine regulatory agencies
Started September 2010
4. Refining the most suitable models for use in medicines
regulation to create a new benefit-risk tool
Not started
5. Training European assessors to use the final tool
Not started
The Agency has now published the Report of Work Package 1 3 which describes the current practice of benefit-risk assessment for centralised procedures in the EU regulatory network based on interviews with six regulatory
agencies (France, Germany, The Netherlands, Spain, Sweden and the United
Kingdom). The benefit-risk balance is generally considered as the most difficult part of the assessment process, even for experienced assessors. It was
mentioned that the most challenging situations are those in which there is
substantial uncertainty about the benefits and the risks of a product: the products belong to a new class of drugs or the products belong to the therapeutic
area of oncology.
At the end of Work Package 4, the Agency is scheduled to launch a public
consultation on the first four work packages and organise a workshop (presumably in 2012).
AESGP is following this issue closely in light of the WSMI project presented
by Cavan REDMOND in Rome (AESGP Euro OTC News No 223, p. 8).
This work will lead to a proposal for a new approach concerning benefit-risk
assessment from the side of the self-medication industry.
New EMA Publications
ICH M2 &
M3(R2) Q&As
In the past few weeks, the Agency has released the following documents of
relevance for the non-prescription medicines sector:
1
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&
murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac0580223ed6&jsenabled=true
2
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109477.pdf
3
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109478.pdf
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• ICH Guideline M2 – Questions and Answers 1 . A new Q&A has been
added with regard to acceptable PDF versions.
• ICH Guideline M3 (R2) – Questions and Answers 2 . This document clarifies the M3(R2) Guidance on “non-clinical safety studies for the conduct
of human clinical trials and marketing authorisation for pharmaceuticals”
with regard to limited dose, reversibility response and metabolite response.
Both documents reached Step 5 at the Cincinnati ICH meetings in June 2011.
Mandate of the
CMDh WG on
ASMF Procedures
At the moment, the same Active Substance Master File which contains information on the drug substance can be assessed by different Member States
or Rapporteurs. This can result in duplication of work, inefficient use of assessor resources, and inconsistent decisions being made on the same data.
With the aim of streamlining resources, a working group on Active Substance
Master File was established by the Co-ordination Group for the Mutual Recognition and Decentralised Procedures – Human (CMDh) in order to deal
with the procedural aspects of coordinated ASMF assessments and to develop
guidelines on worksharing. AESGP and other interested parties participated
in a brainstorming meeting on 12 April 2011 around the role and focus of this
new group (AESGP Euro OTC News No 220, p. 13) . At their meeting in
May 2011, the CMDh adopted the recently published Mandate of the Working Group on Active Substance Master File (ASMF) Procedures 3 .
The Working Party will meet in the margins of the CMDh/CHMP plenary
meetings on a monthly basis, if necessary. It may also make use of IT facilities such as teleconferences.
Community Procedures on Inspections and Exchange of Information
A revision of the Compilation of Community Procedures on Inspections and
Exchange of Information 4 which concerns the deletion of the section ‘Exchange of Information on Manufacturers and Manufacturing or Wholesale
Distribution Authorisations Between Competent Authorities in the European
Economic Area’ as agreed at the GMP / GDP Inspectors Working Group (2426/05/2011).
Final Report on
Trans-Atlantic
administrative
simplification
The Final report on implementation of its transatlantic administrative simplification (TAS) action plan 5 (see also AESGP Euro OTC News No 223, p. 42).
In future the TAS updates will not be subject to a stand-alone report but will
be incorporated in the annual report of interactions between the EMA and the
U.S. FDA.
AESGP CONSULTED
Revision of guideline on nonclinical local tolerance testing
In the past few weeks, AESGP has been consulted on the following draft
documents [consulting body; deadline for comments to AESGP]:
• A Concept Paper on the need for revision of the Guideline on non-clinical
local tolerance testing of medicinal products [EMA; 8 October 2011]. Lo-
1
http://estri.ich.org/eCTD/eCTDQAV1_20.xls
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500109298.pdf
3
http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2011/07/WC500108525.pdf
4
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC5000047
06.pdf
5
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109672
2
AESGP Euro OTC News No. 225
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cal tolerance should be evaluated prior to human exposure of a product in
order to ascertain whether the product (both active substance and excipients) is tolerated at contact sites of the body following clinical use. Various in vitro test systems are currently used for different purposes and at
different time-points within the non-clinical development programme.
Wherever possible, studies on animals, including studies on local tolerance, should be substituted by validated in vitro tests in accordance with
the 3Rs principles. Therefore, the CHMP recommends revising the Guideline on Non-Clinical Local Tolerance Testing of Medicinal Products in order to take into account scientific and legislative progress and to formulate
recommendation on when and how 3R alternatives (replacement, reduction
and refinement) can be considered for regulatory acceptance.
Stability Testing
for applications for
variations to a
marketing authorisation
• A draft Guideline on stability testing for applications for variations to a
marketing authorisation 1 [EMA; 6 January 2012] which aims at outlining
the stability data which have to be generated in case of variations intended
to apply to chemical active substances and related finished products,
herbal substances and preparations and related herbal medicinal products.
It provides general guidance on stability testing in case of type I (A and B)
variations and addresses in more details the information required for active
substances and/or finished products in widely encountered cases of type II
variations as listed in section 6.
Input requested on
SME Roundtable
AESGP has also been asked for input on an EMA Roundtable on the SME
Initiative that will be held on 3 October 2011 with the objective of providing
an update on the implementation of the SME initiative, discussing current and
future issues SMEs are facing and listening to industry’s views and future expectations. AESGP Director General Hubertus Cranz will present the views
of AESGP. Topics to be covered in the roundtable discussion include:
• Current and future SME incentives
• Reduction of red tape and administrative simplification
• eCTD
• Pharmacovigilance
• SME office and links with national and international structures supporting
small companies.
Input on these and other topics of relevance to SMEs should be sent to
AESGP by 31 August 2011.
AESGP SUBMITS COMMENTS ON REVISION OF CHAPTER 8 - GMP GUIDE
Risk-based approach in quality
defects appreciated
1
2
In its comments on the Concept paper on Revising Chapter 8 of the EC guide
to GMP to introduce risk-based concepts and to provide for more effective
investigations and CAPA actions 2 AESGP welcomed the approach taken by
the Agency in the revision of Chapter 8 to adopt a more risk-based approach
in the investigation of quality defects and complaints and in the decision making process for the recall of a product. In particular, said AESGP, “it will be
important to ensure that “the level of effort, formality and documentation of
the quality risk management process should be commensurate with the level
of risk” (ICH Q9/EU GMP Annex 20). It should therefore be accepted that
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109470.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105200.pdf
AESGP Euro OTC News No. 225
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8 August 2011
not all complaints require the same depth of investigation. Qualitative risk
assessment may be appropriate instead of a detailed score-based assessment.”
COMMISSION SUMMARISES RESPONSES ON REVISION OF CLINICAL TRIALS
DIRECTIVE
Total of 143 responses received
As reported in AESGP Euro OTC News No 219, p. 25-27, the European
Commission in February 2011 launched a public consultation on a concept
paper concerning the revision of the ‘Clinical Trials Directive 2001/20/EC’
(CTD). AESGP submitted comments on 13 May 2011 (for details see
AESGP Euro OTC News No 222, p. 5-9). In total, the Commission received
143 responses 1 : 52 from hospitals, investigators and ‘non-commercial’ / ‘academic’ sponsors, 37 from the pharmaceutical industry and contract research
organisations (CROs), 17 from national competent authorities (NCAs), ministries or agencies, including the European Medicines Agency (EMA), 14 from
patient organisations, six from Ethics Committees and 17 from other entities
and individuals. From the Summary of these responses 2 , the points below are
worth noting.
Single EU-Portal
Practically all respondents welcomed the concept of a single EU-portal. This
concept (also referred to as ‘one-stop’ or ‘one-file concept’) was a ‘crucial
prerequisite’, independently of the assessment type.
Separate assessments
Practically all respondents (including AESGP) agreed that, in the case of
separate assessment, the burden of a single EU-portal would outweigh its
benefits. However, some respondents argued that the present system of separate assessment by individual Member States produces positive effects in
terms of competition in the speed and efficiency of the approval, that patients
get a better hearing under the existing system and that divergence and variability of assessment is not necessarily negative.
Centralised assessment
Virtually all respondents (including AESGP) agreed with the preliminary assessment in the concept Paper. A ‘central procedure’ would save resources in
Member States and avoid repetitive assessments. Clinical research programmes for new medicines would be facilitated and the adding-on of centres
in other Member States would be simplified.
Coordinated Assessment Procedure (CAP)
By far the majority of respondents (including AESGP) welcomed the idea of
a Coordinated Assessment Procedure (CAP) as set out in the concept paper.
It was stressed that the experience with the ‘Voluntary Harmonised Procedure’ (‘VHP’) could be put to good use. However, the idea of separating Ethics Committee and national competent authority tasks was rejected: it was
argued that it was ‘not realistic’ or even ‘absurd’ to make such a separation.
As an alternative, several respondents put forward other ideas, such as a ‘coordinated ethics procedure’, where the respective roles of NCAs and Ethics
Committees should be harmonised, while remaining ‘clearly separated’
Scope of the CAP
By far the majority of respondents (including AESGP) considered the catalogue to be complete.
1
2
http://ec.europa.eu/health/human-use/clinical-trials/developments/ct_public-consultation_2011_en.htm
http://ec.europa.eu/health/files/clinicaltrials/ctresp_2011-06/ct_summary.pdf
AESGP Euro OTC News No. 225
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Disagreement between Member
States in the CAP
Several respondents (including AESGP) stressed that, in order for an ‘optout’ to work, there first has to be a group decision from which one can ‘opt
out’. Therefore, an ‘opt-out’ only works in combination with a vote.
Mandatory v optional use of the
CAP
This consultation item was one of the few topics where responses diverged
strongly. Many respondents argued in favour of a ‘phase-in’ (‘pilot phase’,
‘learning curve’, ‘transition period’), i.e. the CAP would become obligatory
only a few years after it had come into operation. The AESGP proposal went
in this sense. The CAP should however not become more cumbersome than
the current procedure for mono-national trials.
Timelines, tacit
approval and
‘Type-A trials’
As regards timelines, there was broad agreement that a CAP should not lead
to longer timelines than at present. The majority of respondents welcomed
the concept of type-A trials in principle – also with a view to the workload of
the approving body. Many respondents (including AESGP) drew attention to
the ongoing work in the UK in this respect as well as to the U.S. (21 CFR
312.2(b)) and the Canadian systems.
Virtually all respondents requested further clarification concerning preassessment and definition. Various other factors should be taken into account, such as the trial phase, the type of products (such as herbal medicinal
products and vitamins) or whether the IMP is modified.
As regards timelines for the pre-assessment, it was stressed that these should
not be longer than a week. The idea of a ‘tacit agreement with a preassessment by the sponsor’ after one week was put forward (also by AESGP).
Interventional /
non-interventional
trials
By far the majority of respondents (including AESGP) agreed that the definition of a ‘non-interventional trial’ should not be widened. It was suggested
that the concept of an ‘interventional trial’ and not that of a ‘noninterventional trial’ should be defined.
Clinical trials by
non-commercial
sponsors
All 143 respondents (with one nuanced response) agreed that clinical trials
conducted by ‘academic / non-commercial’ sponsors should not be excluded
from the scope of the CTD. The main argument throughout the responses
was that the rules on safety, rights, and robustness of data should apply independently of whether or not the sponsor is ‘academic’ / ’non-commercial’.
Insurance requirement
On removing insurance, there were very mixed reactions amongst respondents. AESGP was against the complete removal of insurance.
Single sponsor
Several respondents (including AESGP) argued that single sponsorship is the
better concept as otherwise there might be ‘gaps’ in responsibility. A network of several contracts was an undesirable scenario. It was argued that a
concept of ‘multiple sponsorship’ might lead to ‘collective blame’.
Third country
clinical trials
Practically all respondents stressed that it should be acceptable to have a
clinical trial registered in other public databases than the ‘Clinical Trials Register’. Clarification was needed with respect to the timing of entering this information, in view of retrospective registration.
AESGP Euro OTC News No. 225
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HERBAL NEWS
HMPC adopts six new monographs as final
All but one
adopted by consensus
It appears from the Report from the 11-12 July 2011 meeting1 of the Committee on Herbal Medicinal Products (HMPC) that the following Community
herbal monographs were adopted as final (by consensus except for the monograph on Yarrow flower):
• Achillea millefolium L., herba (Yarrow)
• Achillea millefolium L., flos (Yarrow Flower)
• Capsella bursa-pastoris (L.) Medikus, herba (Shepherds Purse)
• Commiphora molmol Engler, gummi-resina (Myrrh)
• Filipendula ulmaria (L.) Maxim., herba (Meadowsweet)
• Filipendula ulmaria (L.) Maxim., flos (Meadowsweet Flower)
Five draft monographs to be released for comments
The following draft Community herbal monographs were adopted for public
consultation and will soon be published on the EMA website:
• Fraxinus excelsior L. and Fraxinus oxyphylla M. Bieb, folium (Ash Leaf)
• Glycyrrhiza glabra L. and/or Glycyrrhiza inflate Bat and/or Glycyrrhiza
uralensis Fish, radix (Liquorice Root)
• Rhodiola rosea L., rhizoma et radix (Arctic Root)
• Symphytum officinale L., radix (Comfry Root)
• Zingiber officinale Roscoe, rhizoma (Ginger).
Rapporteurs appointed and Calls
for scientific data
launched on
seven plants…
Rapporteurs were appointed and Calls for scientific data were launched for
the establishment of monographs / list entries on:
• Origanum dictamnus L., herba (Cretan Oregano Herb)
• Prunus africana (Hook f.) Kalkm., cortex (Pygeum Africanum Bark)
• Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill., aetheroleum
(Rose Oil)
• Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill, flos (Rose
Flower)
• Adhatoda vasica Nees, folium (Malabar Nut Leaf)
• Picrorhiza kurroa Royle ex. Benth., rhizoma et radix (Katula)
• Withania somnifera (L.) Dunal, radix (Winter Cherry).
…including three
plants used in Ayurvedic medicine
The appointments and calls for scientific data on the last three plants (Malabar Nut Leaf, Katula and Winter Cherry) were made within the context of the
submission by the Indian Authorities of eight proposals for monographs on
medicinal plants used in Ayurvedic medicine. The Committee has investigated the period and extent of use of the plants and noted that the preliminary
information gathered might support a traditional use in the EU in the last 15
years for these three plants whilst two other were already covered by a monograph. The HMPC looks forward to receiving further evidence of the medicinal uses for the above-mentioned three herbal substances from the Indian Authorities and from any interested party.
Comments have been invited to reach AESGP by 4 November 2011 COB.
1
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2011/07/WC500109486.pdf
AESGP Euro OTC News No. 225
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MLWP to look at
AESGP comments on Bearberry Leaf
The AESGP comments on the final Community Herbal Monograph on Arctostahpylos uva-ursi (L.) Spreng., folium (Bearberry Leaf) submitted to the
HMPC Secretariat on 8 July 2011 concerned in particular the gender-specific
indication (use recommended only in women; addition of a sentence dissuading the use in men). The final Assessment Report explained the reasons for
the gender-specific indication as follows: “Although according to reports on
the traditional use no differentiation between the genders was made, the use
of bearberry leaf products is recommended for women only. While recurrent
mild infections of the lower urinary tract are usually uncomplicated in
women, a delayed consultation of a medical doctor may imply to serious risks
for men (for example in case of acute prostatitis or acute epididymitis). This
is the reason why men are excluded from the traditional use.” The Working
Party on Community Monographs and Community List (MLWP) has acknowledged these comments and said that they “will be assessed and discussed at the September meeting of the MLWP. If endorsed, the adopted set
of documents will be revised.”
AESGP consulted
Guidance for
companies seeking scientific support and advice
The HMPC is consulting AESGP on a Guidance for companies seeking scientific support and advice on traditional herbal medicinal products 1 . It should
be used in conjunction with the revised Template for submission of a request
for scientific support and advice on a traditional herbal medicinal product 2 .
Before asking for advice, companies are suggested to look at the other possible options to obtain guidance on herbal medicinal products (e.g. national advice, scientific advice).
Procedure for the
systematic review
of monographs
and supporting
documents
The HMPC is also consulting AESGP on a Procedure for the systematic review of Community herbal monographs and supporting documents 3 which
addresses the scope, timelines and documenting aspects of the review and
possible subsequent revision. The systematic review (assessment of the need
for revision) by the HMPC of its Community herbal monographs is laid down
in section 3.2 of the Reflection paper on the reasons and timelines for revision
of final Community herbal monographs and Community list entries 4 .
The need for a revision will be considered every five years in order to ensure
that Community herbal monographs remain up-to-date (scientific state of the
art). The same procedure applies to Community list entries as implied in Article 16f(3) of Directive 2004/24/EC. The revision of Community list entries
will take place in parallel to or shortly after the revision of related monographs.
Comments on both drafts have been invited to reach AESGP by 28 October
2011.
1
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2011/07/WC5001091
41.pdf
2
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/12/WC500017164.pdf
3
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2011/07/WC5001091
43.pdf
4
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500017022.pdf
AESGP Euro OTC News No. 225
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Calls launched
for scientific data
on adopted
monographs
The HMPC has recently released Revision 4 of the Procedure for calls for
scientific data for use in HMPC assessment work 1 . The revision concerns,
amongst others, the introduction of calls for data to support the give-yearly
review of adopted monographs. Under this revised procedure, the HMPC has
launched Calls for scientific data for the systematic review of monographs on
the following plants: Linseed; Melissa Leaf; Passion Flower; Anise Oil;
Aniseed; Ispaghula Seed; Ispaghula Husk; Primula Flower; Primula Root; and
Valerian Root. Comments have been invited to reach AESGP by 4 November 2011 COB.
Other HMPC publications
Revised templates and
more…
• In the past few weeks, the HMPC has released the following documents:
• A revised Template for a Community herbal monograph2. Amongst other
changes, it may be noted that the following has been added under 4.1
Therapeutic indications for traditional use: “<after serious conditions have
been excluded by a medical doctor>”.
• The final Template for a public statement when no Community herbal
monograph is established3.
• The final Procedure on the publication of HMPC public statements when
Community herbal monographs on herbal substances, preparations and/or
combinations thereof are not established4
• A Template for submission by HMPC members or national competent authorities of questions for discussion by the HMPC5
• A Template for information exchange for the preparation of the assessment
report supporting the establishment of Community monographs and Community list entries6
• Updates of the Overview of assessment work – priority list7 and of the
Inventory of herbal substances for assessment8
• The Report of the hearing9 of the HMPC Working Party on Community
Monographs and Community List (MLWP) with AESGP of 11 May 2011.
PhVWP warns on allergic reactions after exposure to Ispaghula seeds
Recent Spanish
report indicates
respiratory problems in health
professionals
The report of the 18-20 July 2011 meeting 10 of the EMA Pharmacovigilance
Working Party (PhVWP) mentions that discussions were held on the risk of
allergic reactions after prolonged occupational exposure to Plantago ovata
(Ispaghula Seeds). The Spanish competent authorities informed the PhVWP
of 31 case reports of allergic reactions associated with powder formulations
1
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/12/WC5000170
82.pdf
2
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/12/WC500017411.pdf
3
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2011/02/WC500102096.pdf
4
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2011/07/WC5001091
44.pdf
5
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2011/07/WC500109148.pdf
6
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109146
7
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017724
8
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017723
9
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109145.pdf
10
http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500109581
AESGP Euro OTC News No. 225
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8 August 2011
of Plantago ovata seeds received through the Spanish pharmacovigilance reporting system. Most of these cases (25) were reported recently in healthcare
professionals who unintentionally inhaled the seed powder who had been
handling these products for years while preparing them for administration to
patients. These individuals predominantly presented respiratory symptoms
(rhinitis, asthma), severe in some persons, shortly after inhalation of the powder.
According to the results of a study performed in Spain in a sample of healthcare professionals in geriatric care homes who had been repeatedly exposed
to Plantago ovata seed products, about 9% of healthcare professionals suffered allergic reactions confirmed by allergy tests. Plantago ovata seedcontaining products are available as powder or as granules for oral use. The
safety concern is related to the inhalation of the product in powder formulation, since the particles in this formulation, before dissolution in water, are
sufficiently small to become airborne and reach the airways.”
Similar nonserious reactions
reported by other
countries
“The PhVWP considered that the studies published in the past in different
countries show results similar to the recent Spanish study. In addition, cases
have been reported in pharmaceutical industry workers manipulating the
seeds during the manufacturing which are also similar to the cases in healthcare professionals. On the other hand, the PhVWP considered that, although
these products are available in most Member States of the EU, only a limited
number of cases of allergic reactions have been reported in patients using
Plantago ovata, and most of them were non-serious.”
Significant proportion (9%) shows
allergic reactions…
“Based on the review of the data, the PhVWP concluded that allergic symptoms, confirmed by allergic tests, were present in a significant proportion
(around 9%) of persons with prolonged occupational exposure to Plantago
ovata seed powder. Some cases were serious (asthma, anaphylactic reactions
with hypotension). Persons with atopy (i.e. genetic tendency to develop allergies involving the capacity to produce IgE in response to common environmental proteins) were considered to be at increased risk. As with other
allergic reactions, avoiding exposure to the causal agent (by inhalation or ingestion) is the best way to prevent the adverse events in the sensitised population.”
…so awareness
should be increased
The PhVWP considered it relevant to increase the awareness of the risk of
allergic reactions associated with Plantago ovata seed-containing products as
powder formulations in healthcare professionals, caregivers and workers in
the pharmaceutical industry and to warn them that stopping exposure is
needed and that future exposure to these products is to be avoided in the case
of proven allergic sensitisation. The summaries of products characteristics
and package leaflets of these products should be updated to include this information.”
AESGP Euro OTC News No. 225
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8 August 2011
FOOD NEWS
HEALTH CLAIMS
EFSA publishes sixth and final series of Article 13 health claim opinions
35 claims covered
in five opinions
The European Food Safety Authority on 28 July 2011 published the sixth series of scientific opinions on Article 13(1) health claims, thereby finalising
the assessment of all so-called “general function” health claims on nonbotanical substances. The five opinions published cover 35 health claims related to monacolin K from red yeast rice 1 , soy isoflavones 2 , carbonate and
bicarbonate salts of sodium and potassium 3 , creatine 4 and sodium and potassium salts of citric acid 5 .
1 548 claims on
botanicals “put on
hold”
In the press release accompanying the publication 6 , the Authority noted that
the publication of the final series of evaluations is the culmination of more
than three years’ work by experts of the EFSA Panel on dietetic products, nutrition and allergies. Out of the 4 637 health claims submitted to the European Food Safety Authority, 2 758 claims were evaluated in the six series of
scientific opinions 7 , 331 claims were withdrawn, and 1 548 claims on “botanicals” have been placed on hold by the European Commission pending further consideration on how to proceed with these claims.
About 20% of
evaluations were
favourable
The outcomes of the evaluations were favourable when there was sufficient
evidence to support the claims (about one in five claims), which related
mainly to: vitamins and minerals; specific dietary fibres related to blood glucose control, blood cholesterol, or weight management; live yoghurt cultures
and lactose digestion; antioxidant effects of polyphenols in olive oil; walnuts
and improved function of blood vessels; meal replacement and weight control; fatty acids and function of the heart; the role of a range of sugar replacers (such as xylitol and sorbitol) in maintaining tooth mineralisation or lowering the increase of blood glucose levels after meals; carbohydrate-electrolyte
drinks / creatine and sports performance.
Applications help
desk planned
Commenting on the finalisation of the scientific assessment of non-botanical
health claims, EFSA’s Executive Director Catherine GESLAINLANÉELLE said: “EFSA’s work on general function health claims has highlighted the importance of constructive dialogue between risk assessors, scientists, decision-makers and stakeholders and has contributed to our thinking on
the future shape of our organisation. As a result, EFSA plans to launch an
applications help desk to facilitate dialogue with applicants. By ensuring that
there is a shared understanding of the scientific evidence required, the work
we have undertaken will, we trust, support the work of industry by helping to
establish future directions for research and innovation.”
1
2
3
4
5
6
7
http://www.efsa.europa.eu/en/efsajournal/pub/2304.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2264.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2301.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2303.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2302.htm
http://www.efsa.europa.eu/en/press/news/110728.htm
The six series of scientific opinions were published on 1 October 2009, 25 February 2010, 19 October 2010, 8 April
2011, 30 June 2011 and 28 July 2011.
AESGP Euro OTC News No. 225
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8 August 2011
Commissioner
Dalli thanks
EFSA for “valuable input”…
The European Commission welcomed the publication of the sixth set 1 : “Ensuring accurate and reliable information on food labels is key to help consumers make healthier choices and strengthen their empowerment”, Health
and Consumer Policy Commissioner John DALLI said. “The assessment
process, conducted by EFSA so far, is a vital step towards the implementation
of the Nutrition and Health Claims Regulation, and I thank EFSA for its valuable input to this difficult and challenging task that has no precedent anywhere else in the world”, he added. “Now our priority is to adopt, as soon as
possible, the list of permitted Article 13 claims.”
…and aims to present final measure
to the Member
States before year
end
The European Commission confirmed that it had started preliminary work
with the Member States aimed at presenting the final measure before the end
of 2011. The draft EU list of permitted Article 13 health claims could therefore be submitted to the Standing Committee on the Food Chain and Animal
Health – section General Food Law (composed of representatives of national
competent authorities) for possible adoption at the meeting scheduled for 5
December 2011 2 . Following a possible favourable opinion from the Standing
Committee, the European Parliament (and the Council) would then have a
three-month scrutiny period of the draft list – which can only be formally
adopted in case no objections are raised. The transitional arrangements will
start following publication of the list of permitted Article 13 health claims in
the Official Journal of the European Union.
Process for “further assessment”
started
In parallel, the European Food Safety Authority is liaising with the European
Commission and the Member States regarding the process of so-called “further assessment” of those health claims for which the European Food Safety
Authority’s assessment was considered as not conclusive (see also AESGP
Euro OTC News No 223, p. 43-44). These are:
(1) health claims on micro-organisms which EFSA considered as insufficiently characterised to proceed with an assessment of the evidence and
(2) health claims for which the Authority concluded that “the evidence provided is insufficient to establish a cause-and-effect relationship” during
its initial assessment.
EFSA expects it will receive the claims for reassessment from the European
Commission before the end of 2011, and will draw up a precise timetable for
their further assessment once the resubmission process has been completed.
NEW EFSA OPINIONS
Opinions on three Article 13(5) and two Article 14 health claims…
Slowly digestible
starch and reduction of glycaemic
responses
In its Opinion on the substantiation of a health claim related to “slowly digestible starch in starch-containing foods” and “reduction of post-prandial
glycaemic responses” 3 (Article 13(5) health claim based on newly developed
scientific evidence and including a request for the protection of proprietary
data), the EFSA Scientific Panel on dietetic products, nutrition and allergies
(NDA Panel) noted that the food constituent being the subject of the health
1
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/933&format=HTML&aged=0&language=EN&guiLan
guage=en
2
http://ec.europa.eu/food/committees/regulatory/planning_sc_meetings_2011.pdf
3
http://www.efsa.europa.eu/en/efsajournal/pub/2292.htm
AESGP Euro OTC News No. 225
- 14 -
8 August 2011
claim is “slowly digestible starch” (SDS) as compared to “rapidly digestible
starch” (RDS) in starch-containing foods., and considered them as sufficiently
characterised in relation to the claimed effect proposed by the applicant i.e.
the reduction of post-prandial glycaemic responses in the general population.
The Panel concluded that a cause-and-effect relationship had been established
between the consumption of SDS, as compared to the consumption of RDS,
in cereal products and reduced post-prandial glycaemic responses (without
disproportionally increased post-prandial insulinaemic responses). Four unpublished studies claimed as proprietary by the applicant were required to establish the conditions of use for this specific claim.
Proposed wording
The Panel considered that the following wording reflected the scientific evidence: “Consumption of cereal products high in slowly digestible starch
raises blood glucose concentrations less after a meal than cereal products low
in slowly digestible starch”. In order to bear the claim, cereal products
should, according to the Panel, contain at least 55% of available carbohydrates as starch of which at least 40% should be “slowly digestible starch”.
The target population is individuals who wish to reduce their post-prandial
blood glucose responses.
L-tyrosine and
synthesis of dopamine
In the Opinion on the substantiation of a health claim related to L-tyrosine
and contribution to normal synthesis of dopamine 1 (Article 13.5 health
claim), the NDA Panel concluded that a cause-and-effect relationship had
been established between the consumption of L-tyrosine in a protein adequate
diet and contribution to normal synthesis of dopamine. The Panel noted however that no evidence had been provided that the protein supply in the diet of
the European population is not sufficient to fulfil this function of the amino
acid.
Proposed wording
The Panel considered that the following wording reflected the scientific evidence: “L-tyrosine contributes to normal synthesis of dopamine” and that in
order to bear the claim a food should be at least a source of protein as per Annex to the Nutrition and Health Claims Regulation (an amount that can be
easily consumed as part of a balanced diet). The target population is the general population.
Collagen hydrolysate and joint
maintenance
In the Opinion on the substantiation of a health claim related to collagen hydrolysate and maintenance of joints (Article 13.5 health claim including a request for the protection of proprietary data), the NDA Panel came to the conclusion that a cause-and-effect relationship had not been established between
the consumption of collagen hydrolysate and the maintenance of joints.
Microbial combination and modulation of the intestinal microflora
The NDA Panel also evaluated the substantiation of a health claim related to a
combination of Lactobacillus delbrueckii subsp. bulgaricus AY/CSL (LMG
P-17224) and Streptococcus thermophilus 9Y/CSL (LMG P-17225) and
“beneficial modulation of intestinal microflora” 2 (Article 14 health claim referring to children’s development and health). The Panel considered that the
food constituent which is the subject of the health claim had not been sufficiently characterised and noted that, according to the Nutrition and Health
1
2
http://www.efsa.europa.eu/en/efsajournal/pub/2290.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2288.htm
AESGP Euro OTC News No. 225
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8 August 2011
Claims Regulation, the use of health claims is only permitted if the food /
constituent for which the claim is made has been shown to have a beneficial
physiological effect. Based on current scientific knowledge, the Panel noted
that it is not possible to define the exact numbers / proportions of the different
microbial groups which constitute a “beneficial” or “normal” intestinal microbiota, and that increasing the number of any group of microorganisms, including lactobacilli and/or bifidobacteria, is not considered in itself a beneficial physiological effect. The applicant was therefore requested to provide
the rationale regarding the extent to which the claimed effect is a beneficial
physiological effect, but no reply was received to the Panel’s request for supplementary information. The Panel considered that no evidence had been
provided by the applicant to establish that the claimed effect, “beneficial
modulation of the intestinal microflora", is a beneficial physiological effect
and concluded that, on the basis of the data presented, a cause-and-effect relationship had not been established between the consumption of the food constituent and a beneficial physiological effect related to “beneficial modulation
of the intestinal microflora”.
Beta-palmitate
and increased
calcium absorption
Finally, in the Opinion on the substantiation of a health claim related to betapalmitate and increased calcium absorption 1 (Article 14 health claim),
EFSA’s scientists concluded that the evidence provided was insufficient to
establish a cause-and-effect relationship between the consumption of betapalmitate and an increase in calcium absorption. In weighing the evidence,
the Panel took into account the biological plausibility of the mechanism by
which beta-palmitate could exert the claimed effect and that three small human intervention studies in preterm and term infants provided some evidence
that a higher degree of palmitic acid in the sn-2 position of formula triglycerides may increase calcium absorption by decreasing faecal calcium excretion as calcium soaps, albeit a significant effect on calcium absorption was
demonstrated in one study only.
…and on a novel food ingredient
Glavonoid®
found safe under
normal conditions of use
1
2
The EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies was
also asked to evaluate the safety of ‘Glavonoid®’ (an extract derived from the
roots or rootstock of Glycyrrhiza glabra L.) as a novel food ingredient 2 . Glavonoid® is an extract rich in polyphenolic type substances, derived from the
root or rootstock of Glycyrrhiza glabra L. (liquorice root - a member of the
Fabaceae family) by extraction with ethanol, and has a history of human consumption. The applicant intends to market Glavonoid as food supplements
and as an ingredient for fruit juices, yoghurts and yoghurt drinks up to a dose
of 300 mg per day for the general adult population. The Panel considered that
the human studies provided did not raise safety concerns and that there are no
concerns related to genotoxicity. Regarding the uncertainties concerning a
possible impact on anticoagulant therapy, the Panel noted that no studies were
conducted to evaluate a possible interaction between Glavonoid and drugs on
blood coagulation. The Panel concluded that the novel food ingredient Glavonoid was safe for the general adult population up to 120 mg/day. However,
the Panel noted that the safety of Glavonoid for pregnant and breast-feeding
women had not been established.
http://www.efsa.europa.eu/en/efsajournal/pub/2289.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2287.htm
AESGP Euro OTC News No. 225
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8 August 2011
COUNTRY NEWS
GERMANY
Switches and reverse switches
Several decisions
postponed
On 5 July 2011, the German Expert Committee for Prescription decided to
recommend an increase of single-dose nicotine available without a prescription as a smoking cessation aid from 10 to 15mg. The Committee turned
down the switch to non-prescription status of the migraine treatments Rizatriptan 10mg tablets and Sumatriptan 20mg nose spray. It further approved
the decision to back switch Ketoprofen for topical use to prescription status as
recommended earlier by the CHMP (AESGP Euro OTC News No 213, p. 7).
The Expert Committee postponed the decision on a back switch of dextrometophan to prescription status to a later session. Deliberations on a back
switch of paracetamol were postponed given that the BfArM is conducting a
thorough review of all analgesic ingredients, including paracetamol.
Extra meeting on
analgesics in September
In the meantime is has been announced that the Expert Committee will hold an
extraordinary meeting to discuss the introduction of pack size limitations for the
non-prescription use of medicines with the active ingredients Acetylsalicylic
acid, Diclofenac, Ibuprofen, Naproxen, Phenazon and Propyphenazon and a
possible adaptation of the length of treatment to four days.
Self-medication budget being discussed
Insurance companies would reimburse a certain
sum at year-end
In order to improve self-responsibility in healthcare and to increase the importance of self-medication, the German Medicines Manufacturers’ Association BAH has recently started a project aimed at installing a self-medication
budget. Evidence suggests that establishing a self-medication budget is one
of the most effective ways of improving self-medication within the German
healthcare system. This means that insurance companies would reimburse its
members at the end of the year for part of the non-prescription medicines purchased in pharmacies during the year without a prescription. The extent of
the budget still needs to be determined. Ultimately such a self-medication
budget would have a cost-saving effect for insurance companies in the absence of fee charges from prescribing doctors.
The BAH is convinced that the introduction of a self-medication budget will
create a win-win situation for patients, pharmacists and the manufacturers of
non-prescription medicines.
BAH continues promotion of the ‘Green Prescription’ form
Research data
show
AESGP Euro OTC News No. 225
The ‘green prescription’ form is another successful instrument to improve the
image and the value of non-prescription products. New IMS Health data
show that every fifth prescription of an OTC product is done on a ‘green prescription’ form. Meanwhile almost 70% of GPs are frequently using the
‘green prescriptions’. A survey carried out by market researcher Nielsen has
shown that 83% of GP prescription on the ‘green form’ are presented in
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8 August 2011
pharmacies by people following the doctor’s advice. Another 3% of patients
with a ‘green prescription’ bought the recommended product without presenting the form. In 2011 the “Initiative Grünes Rezept” is going to support doctor recommendations of non-prescription medicines by distributing approximately 15 million ‘green prescription’ forms. Further information is available
on www.ini.gruenerezepte.de.
SPAIN
New Guideline on Invented Names should increase certainty for manufacturers of
non-prescription medicines
New guideline
based on anefp
draft proposal
The Spanish Medicines Agency (AEMPS) on 1 August 2011 published a new
Guideline on the Acceptability of Invented Names for Medicinal products 1 .
The acceptance of umbrella brand namess for non-prescription medicines has
for a long time been a critical issue for the Spanish self-care association anefp
given that umbrella brand names are part of an effective business development strategy and promote market growth. However, the Spanish Health Authorities, who are traditionally very protective of the consumer, have been
very reluctant to accept umbrella brands because of the potential risk of confusion on the part of both pharmacists and citizens.
In late 2010 anefp sent a new Draft Guideline on the Acceptability of Invented
Names for Non-Prescription Medicinal Products to the new Director of the
Spanish Medicines Agency, Belén Crespo. The newly published text is
strongly inspired by the anefp draft document and was developed thanks to a
good understanding and fine-tuning with the new Director and also with the
Deputy Director of the Agency. Anefp has declared it is really satisfied with
the results.
The guideline will be reviewed by the Agency on a regular basis so that new
criteria may be incorporated over time. In this regard it was agreed that the
cases and examples industry will raise and which are not specifically covered
in the guideline will not automatically be rejected. They will be dealt with on
a case-by-case basis.
Points of relevance from the
new guideline:
importance of
name recognised
In the introduction, the name of a medicinal product is recognised as a key
part of its assets. In analogy to paragraph 2.4.4 of the EU’s Guideline on the
acceptability of names for human medicinal products processed through the
centralised procedure 2 , the document states that - in certain circumstances the name can have a positive connotation and/or be informative.
The guideline is applicable to all medicines for human use until such time as
the AEMPS sets specific criteria for prescription medicines, but it was specially designed for non-prescription medicines “where the name has a special
relevance as patients or users link a medicine’s properties with its name”.
Flexibility introduced
1
2
If the marketing authorisation holder (MAH) decides to propose a name under
the heading: name or scientific name, accompanied by a trade mark or the
name of the marketing authorisation holder, the Competent Authority has introduced a commercially interesting possibility: “The name of the MAH to be
http://www.aemps.gob.es/industria/regMedicamentos/guia-Nomb-MUH.htm
http://www.ema.europa.eu/pdfs/human/regaffair/032898en.pdf
AESGP Euro OTC News No. 225
- 18 -
8 August 2011
included in the name of the medicine may be the official MAH name, complete or abbreviated, or the manufacture’s name, or a trademark belonging to
the owner or manufacturer and which it decides to apply to some or all of the
medicines it owns”.
Abbreviations in
principle allowed
as part of the name
In case of non-prescription medicines, if the selected option for proposing a
name is an invented name, “abbreviations as part of the invented name
should in principle be acceptable in similar terms to those described in the
EU’s ‘Guideline on the acceptability of names for human medicinal products
processed through the centralised procedure’”.
UNITED KINGDOM
PAGB Advertising Codes now online
Codes searchable
by keywords and
by questions
The PAGB Medicines Advertising Codes are now available online at a new
PAGB website 1 designed to make the Consumer Code and Professional Code
easily accessible and user-friendly and ensure they are always up to date.
Features on the website include:
• Advanced search – to help you find the rules relevant to you, you can
search by keywords, a free text search, or by using the menus and prompts
provided.
• Search by questions – these are frequently asked questions. By choosing
the ones relevant to your query, you will be taken to the relevant rule(s).
• Advertising case studies show common mistakes made in over-the-counter
medicines advertising, provide explanations and a link to the relevant
rule(s).
• ‘In Practice’ panels contain handy ‘Do’s and Don’ts’ and highlight the appropriate SmPC sections for quick reference.
N o w is the time to register for the
AESGP Conference
near the European Medicines Agency
How can the availability of nonprescription medicines be improved?
Canary Wharf, London ™ 18-19 October 2011
Programme and registration details on www.aesgp.be
For selected speakers see next page
1
www.pagbadvertisingcode.co.uk
AESGP Euro OTC News No. 225
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8 August 2011
1
Speakers at the AESGP Conference in London, 18‐19 October 2011 Andreas POTT, Acting Execu‐
tive Director, European Medicines Agency
Bert LEUFKENS, CHMP Mem‐
ber, Chair, Medicines Evalua‐
tion Board, Netherlands
Fergus SWEENEY, Head of Sector Compliance and In‐
spection, European Medi‐
cines Agency
Peter ARLETT, Head of Sec‐
tor Pharmacovigilance, Euro‐
pean Medicines Agency
Tomas SALMONSON, CHMP Vice‐Chair, Medical Products Agency, Sweden
Truus JANSE‐DE HOOG, Chair, Co‐ordination Group for the Mutual Recognition and Decentralised Procedures Roger SCARLETT‐SMITH, President, GlaxoSmithKline Consumer Healthcare Europe
Hans REGENAUER, AESGP President
Eric ABADIE, Chair, EMA Committee for Medicinal Products for Human Use (CHMP) Dagmar ROTH‐BEHRENDT, Vice‐President of the Euro‐
pean Parliament
Noël WATHION, Head of Unit Patient Health Protection, European Medicines Agency
Werner KNOESS, Chair, EMA Committee on Herbal Me‐
dicinal Products (HMPC)
AESGP Euro OTC News No. 225
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Emer COOKE, International Affairs, European Medicines Agency
g Christa WIRTHUMER‐HOCHE, Österreichische Agentur für Gesundheit und Ernäh‐
rungssicherheit, Austria
Patrick LE COURTOIS, Head of Unit Human Medicines Development and Evaluation, European Medicines Agency
Peter BACHMANN, Federal Institute for Medicines and Medical Devices, Germany
8 August 2011
1
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