News and updates on pharmaceuticals
Pharmaceuticals Archives - 2004
Maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin in accordance with Regulation (EEC) N° 2377/90.
An updated consolidated version of Annex I to IV of Council Regulation 2377/90 is now available in English.
This document is not an official version and is only intended for use as a search tool. No liability for its content is assumed. In case of doubt, consult the Official Journal. If mistakes are identified, please give feedback .
The Publications Office will proceed to publish an updated consolidated version in all official languages once all Regulations amending Regulation 2377/90 have been translated into the new languages and published. .
Updating the Notice to Applicants - Volume 2A Chapter 7 "General Information"
DG Enterprise and Industry releases an updated version of Chapter 7 "General Information" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation. Clarification are given in respect to the requirements for the new Member States (CZ, MT, LT, LV, PL, SK, SI) and updated for the old Member States (DK, IT and BE).
Study on the price of orphan drugs (see 16/11/04)
ERRATUM: Etude relative au prix des médicaments orphelins - Phase I (Français)
ERRATUM: Study on the price of orphan drugs - Phase I (English)
Draft guideline on similarity of medicinal products and "clinical superiority" related to the orphan regulation
The Commission invites comments on a draft guideline on similarity of medicinal products and "clinical superiority" related to the orphan regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products). Comments should be sent by 4 February 2005 to Dr Peter Arlett, DG Enterprise and Industry. Electronic submissions are preferred and should be sent before the deadline to email@example.com
Please note that the guideline does not cover the application of Article 8 paragraph 2 of the Regulation relating to the reduction of the period of market exclusivity.
The draft guideline can be found by clicking here.
European Court of Justice judgement on the abridged procedure for generic medicinal products
In its judgment of 9 December 2004 in case C-36/03 (APS), the ECJ has ruled that an application for marketing authorisation under the abridged procedure of Article 10(1)(a)(iii) of Directive 2001/83/EC may be made for a generic product claiming to be "essentially similar" to a reference product, where the reference product has not yet been authorised for six/ten years, but is a new pharmaceutical form of an original product authorised for more than six/ten years.
Guideline on the packaging information of veterinary medicinal products authorised by the Community - revision 2a
This Guideline has been updated as regards specific information required by national authorities of the Member States France, Portugal and the Czech Republic to be indicated in the labelling and package insert for veterinary medicinal products authorised by the Community.
Value of Innovation: report of the EPPOSI / European Commission workshop
A workshop was held on 28 June 2004 on 'the Value of Innovation'. The workshop was jointly organised by EPPOSI (European Platform for Patient Organisations, Science and Industry) and the European Commission, DG Enterprise.
The report of the meeting can be found here….
Commission study on Innovation in Pharmaceuticals
The European Commission, DG Enterprise today published an important new study on innovation in pharmaceuticals. The study was stimulated, in part, by the fall in applications for marketing authorisations in 2002 / 2003. The study aimed to investigate: 1. whether there is a crisis in innovation in the pharmaceutical sector; 2. the reasons behind any crisis; and, 3. tools available to kick-start innovation.
The study conducted by Charles River Associates, has important findings for the Commission and all stakeholders involved in pharmaceuticals.
The study report is available by clicking here .
Study on the price of orphan drugs
The Commission has published an independent study on the price of orphan drugs. The study, conducted by Alcimed, looks at the price of orphan drugs authorised in the EU and how these prices were arrived at. In addition, the study discusses how 'sufficient profitability' might be assessed and judged. This latter aspect relates to the operation of Article 8 (market exclusivity) of the Orphan Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products).
The study will inform discussions on the development of both guidelines relating to the operation of Article 8 and the 2006 Commission report foreseen in Article 10 of the Orphan Regulation. Any opinions in this report are those of the authors and do not necessarily reflect those of the European Commission
Please note that the French version is the original one. The English version is a translation.
ERRATUM: Etude relative au prix des m!"dicaments orphelins - Phase I
Consultation on Commission Regulation on the condition marketing authorisation for medicinal products
The European Commission wishes to receive comments on a draft Commission regulation on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004.Article 14 (7) of Regulation (EC) No 726/2004 provides the legal base for the Commission to adopt a regulation setting out the scope, procedures and criteria for granting conditional marketing authorisations through the centralised procedure. Comments on the draft regulation should be sent before 22 December to Dr Peter Arlett, Principal Administrator, European Commission, AN/88/1/55, 1049 Brussels. E-mail submissions are preferred and should be sent to firstname.lastname@example.org.
"Public Consultation on Provisions for Small and Medium-sized Enterprises (SMEs)"
Article 70(2) of Regulation (EC) No 726/2004 foresees specific provisions establishing the circumstances in which SMEs may pay reduced fees, defer payment of the fee, or receive administrative assistance for the marketing authorisation of a medicinal product via the centralised procedure.
The European Commission is currently working on a Commission Regulation, and wishes to consult the main stakeholders on its proposal. The present document aims at providing a basis for this consultation, as well as stimulating discussion with interested parties, by outlining the key elements put forward by the Commission. Comments are kindly requested before 26th November 2004 and should be sent to email@example.com.
Implementation plan for regulatory cooperation agreed by EC, EMEA and FDA
In September 2003 the EC, EMEA and FDA signed a confidentiality agreement to allow the exchange of information on centrally authorised products, products referred to the Committee for Human Medicinal products and the development of regulatory policy and pharmaceutical legislation.
I n September 2004 the EC, EMEA and FDA agreed an implementation plan to allow regulatory cooperation to work in practice and increase to reach levels never before achieved. Click here to view the plan.
At the same time as agreeing the implementation plan a framework for parallel scientific advice from the EMEA and FDA was agreed.
Commission adopts proposal for a regulation on medicines for children
On 29 September 2004 the European Commission adopted a proposal for a Regulation of the Council and of the Parliament on Medicinal Products for Paediatric Use. The proposal aims to address the current situation where more than 50% of medicines used to treat children are not specifically tested or authorised for their use. The adoption follows extensive research and consultation on possible solutions to this public health issue and an "Extended Impact Assessment" of the social and economic effects of the proposals on children and their families, healthcare professionals, industry and governments. More details can be found in the section of this web-side dedicated to medicines for children.
Consolidated version of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC is now available in English in the EudraLex Collection Volume 1.
Consolidated version of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended by Directive 2004/28/EC. is now available in English in the EudraLex Collection Volume 5.
The EudraLex Volume 1 and Volume 5 now include the translations for the 9 new EU languages, as far as available at the moment. Note that these translations are not official as long as they are not published in the special editions of the Offical Journal.
Pharmaceutical Committee - Summary record of the 56th meeting 19 January 2004
Pharmaceutical Committee - Summary record of the 55th meeting 15 May 2003
"Updating the Notice To Applicants Volume 2C : guidelines on procedures for VAMF / PMF certification"
Procedural guidelines on Plasma Master File (PMF) and Vaccine Antigen Master File (VAMF) certification are added to the Notice to Applicants, Volume 2C. This includes:
- the guideline on the procedure for VAMF certification
- the guideline on the procedure for PMF certification
- the guideline on the "2nd step", when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).These documents, which have been elaborated in consultation with the interested parties are mainly addressed to Competent Authorities, Marketing Authorisation Applicants and Marketing Authorisation Holders seeking to benefit from the use of the PMF/VAMF system.
Note: Detailed guidance on the scientific requirements for PMF/VAMF certification can be found on the European Medicines Agency website (http://www.emea.europa.eu/).
Revised Commission guideline on applications for orphan medicinal products
The Commission guideline on the "format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another" has been updated. The revisions to the guideline include reference to Icelandic and Norwegian participation in the designation process, EU Enlargement, and cross-reference to the Commission Communication (2003/C 178/02).The Commission conducted a three-month public consultation on the revisions. Two responses to the consultation were received, from the Bioindustry Association and the Emerging Biopharmaceutical Enterprises group within the European Federation of Pharmaceutical Industry Associations. The responses were carefully considered by the Commission in consultation with the EMEA Committee for Orphan Medicinal products. Where possible, the changes suggested in the responses have been included. Some of the suggestions were considered outside the scope of the current revision and will be taken into consideration in the overall review of the orphan regulation foreseen for 2005.
Annex (word format)
Invitation to tender n° ENTR/04/36
Study: Analysis of Pharmaceutical Market Structures in the new Member States
Objectives of the analysis: The aim of the study is to assess the market structure of medicinal products in the new Member States, focusing on all the different market components such as patented medicinal products, generic medicinal products, products authorised in accordance with the Centralised Procedure, products that are nationally authorised, products of local origin, imported products, OTC products and prescription only products. Reimbursement arrangements and protection of intellectual property rights should also be addressed.
The analysis will cover the current situation within the 10 new Member States. The call for tender was published on the 22nd of July 2004 in the OJEU S 2004 / 141-120439. Electronic copies can be found here; paper copies can be requested at the following address: firstname.lastname@example.org. The deadline for submission is 09/09/2004
Updating the Notice To Applicants - Volume 2A Chapter 7 "General Information"
DG Enterprises releases an updated version of Chapter 7 "General Information" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation including information for applications in the centralised procedure, simplified requirements for Malta and Czech Republic and requirements for Malta in the national and mutual recognition procedure.
Guideline on Plasma Master File and Vaccine Antigen Master File '2nd step'
The Commission issues guidance on the so-called "2nd step" of the Vaccine Antigen Master File (VAMF) and Plasma Master File (PMF) certification, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).
The document has been elaborated in consultation with the interested parties, and has been reviewed by the Pharmaceutical Committee. It is mainly addressed to Competent Authorities, Marketing Authorisation Applicants and Marketing Authorisation Holders seeking to benefit from the use of the PMF/VAMF system.
Note: Detailed guidance on the scientific and procedural requirements for the "1st step" of the PMF/VAMF certification can be found on the European Medicines Agency website (http://www.emea.europa.eu/).
Notice to Applicants, Volume 2B, electronic Common Technical Document (eCTD)
Specification v1.0 for the regional EU M1 of the eCTD is now published, along with specification v1.0 for the Electronic Application Form.
The EU M1 specification has been revised and finalised in line with ICH specifications for M2 - M5, and in line with the new CTD structure and guidance. The specification supports Centralised, National and Mutual Recognition procedures.
Consultation on a proposal for a new Annex 19 (Reference Samples and Retention Samples) to the EU GMP Guide (Volume 4)
The new annex to the EU GMP Guide provides guidance on the taking and holding of reference samples of starting materials, packaging materials and finished products as well as for retention samples of finished products. The annex provides definitions of the terms "reference sample" and "retention sample", which are often incorrectly considered as synonyms. The guidance is wide ranging in scope and includes the case of multiple manufacturing sites, the position with respect to importers and what should happen when a manufacturing site ceases to operate. Updated guidance is also given on the size of reference samples and a consequential amendment will therefore be necessary to Chapter 6 section 14 of the GMP Guide to maintain consistency. The Pharmaceutical Committee has endorsed the proposal by written procedure. The document is released for a consultation period until 15 January 2005. Comments should be sent to GMP@emea.eu.int and Karin.Krauss@ec.europa.eu.
Updated version of Chapter 7 General information in volume 6A Notice to Applicants July 2004
Chapter 7 of the Notice to Applicants Volume 6A has been updated as concerns the requirements for the new Member States, which submitted information to the Commission. In addition, changes of addresses, procedure on fee payments and languages required have made to reflect the situation for some Member States.
Draft Commission Proposal for a Council Regulation on the fees payable to the European Medicines Agency
The European Commission wishes to consult interested parties on its draft proposal for a Council Regulation on the fees payable to the European Medicines Agency. The future Regulation will replace existing Council Regulation (EC) No 297/95. The current Regulation will be modified in order to take into account the recently adopted pharmaceutical legislation (Regulation (EC) No 726/2004). Modifications are also proposed taking into consideration the experience gained with the application of the existing Regulation.
On the basis of Article 70(1) of Regulation 726/2004, the new Regulation is to be adopted by the Council of Ministers, on a proposal from the Commission. The Commission has to adopt its proposal once it has consulted organisations representing the interests of the pharmaceutical industry at Community level.
Comments are requested before 20 August 2004 and should be send to Clara.Martinez-Alberola@ec.europa.eu.
Updating the Notice to Applicants - Volume 2A Chapter 7 "General Information"
DG Enterprises releases an updated version of Chapter 7 "General Information" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation including information for applications in the centralised procedure and requirements of the Member States including changes in addresses.
The Commission publishes a summary of the comments received on the reflection paper on control of residues of veterinary medicinal products and Maximum Residue Limits.
The Commission published a reflection paper in December 2003 requesting comments on the various points raised for the reconsideration and possible modification of the Community legislation concerning residues of veterinary medicinal products.
The comments received have been summarised by the Commission in order to provide a general picture of the views expressed by the various parties as an aid in the preparation of future legislative proposals. The summary is not intended to replace the original comments, which could be consulted in parallel.
Draft COMMISSION DIRECTIVE laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of manufacturing or importation of such products
The European Commission wishes to consult stakeholders on its draft proposal for a Directive on Good Clinical Practice. Commission conducted a previous consultation, between April 2002 and July 2002 for the requirements to obtain an authorisation to manufacturing or importing an investigational medicinal product and between June 2002 and September 2002, on the key elements of the Trial Master File, inspections procedure and qualification of inspectors to be included in a Directive. The feedback received, together with views expressed at additional meetings and workshops held with key stakeholders, have been carefully considered and have shaped the draft legislative proposal on which the Commission now consults.
The feedback received from this consultation will be use to finalise the draft legislative proposal.
Comments are requested before 30 July 2004 and should be send to Birka.Lehmann@ec.europa.eu.
Update of Volume 9 "Pharmacovigilance of medicinal products for human use and of veterinary medicinal products
The Volume 9 of "The rules governing medicinal products in the European Union" has been revised to include updated Distribution Requirements for Periodic Safety Update Reports (d.d. 18th June 2004).
Revised orphan guideline released for 3 months consultations
The Commission Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another has been updated with respect to: references to Norway and Iceland participating in the designation process; EU enlargement; and cross references to the Commission Communication (2003/C 178/02).
Comments from interested parties are invited by the Commission before 28 May 2004. Comments should be e-mailed to email@example.com
Updated versions of Chapters 1, 2 and 3 and completely revised chapter 5 in volume 2A Notice to Applicants for Human Medicinal Products
DG Enterprise releases updated versions of Chapters 1, 2, 3 and a major revision of chapter 5 of the Notice to Applicants for Human Medicinal Products on the procedures for marketing authorisations, mutual recognition, community referrals and variations. The changes made are mainly adaptations following the entry into force of the new Commission Regulations (EC) No 1084/2003 and (EC) No 1085/2003 concerning variations to marketing authorisations for products authorised via the mutual recognition procedure and the centralised procedure, respectively. These chapters are part of Volume 2A of The rules governing medicinal products in the European Community.
- Eudralex Volume 2A - Notice to Applicants - Procedure for marketing Authorisation
Updated Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 October 2003) available in all languages of the European Union
This joint CPMP/CVMP Note for Guidance is the second revision of the Note for Guidance on minimising the risk of transmitting TSE via medicinal products. This Note for Guidance will become applicable from 1 July 2004 and replaces the previous version (EMEA/410/01 Rev. 1 July 2001). Compliance with this Note for guidance has to be demonstrated according to Directive 2001/83/EC and Directive 2001/82/EC for human and veterinary medicinal products, respectively.
The revised TSE Guidance Note also makes redundant the CVMP Position paper on the use of starting materials of ruminant origin in veterinary medicinal products intended for use in ruminant species (EMEA/CVMP/121/01 February 2001).
The CVMP Position paper on the assessment of the risk of transmission of animal spongiform encephalopathy agents by master seed materials used in the production of veterinary vaccines (EMEA/CVMP/019/01 February 2001) remains applicable.
Updated versions of Chapters 1, 2 and 3 and completely revised chapter 5 in volume 6A Notice to Applicants January 2004
DG Enterprise releases updated versions of Chapters 1, 2, 3 and a major revision of chapter 5 of the Notice to Applicants for Veterinary Medicinal Products on the procedures for marketing authorisations, mutual recognition, community referrals and variations. The changes made are mainly adaptations following the entry into force of the new Commission Regulations (EC) No 1084/2003 and (EC) No 1085/2003 concerning variations to marketing authorisations for products authorised via the mutual recognition procedure and the centralised procedure, respectively. These chapters are part of Volume 6A of The rules governing medicinal products in the European Community.
Eudralex Volume 6A - Notice to Applicants - Procedure for marketing Authorisation
GMP - Compilation of Community Procedures on Inspections and Exchange of Information
On behalf of the European Commission the EMEA is now responsible for maintaining and publishing the Compilation of Community Procedures. The Compilation is a collection of GMP inspection-related procedures and forms agreed by the GMP inspectorates of all Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information. EMEA is going to reformat, review and update the procedures and incorporate new additions as soon as possible after they have been agreed.
EMEA's inspection website "Compilation of Community Procedures"
Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2C Regulatory Guidelines
Guideline on the packaging information of Human Medicinal Products authorised by the Community
DG Enterprise publishes an updated version of the "Guideline on the packaging information of human medicinal products authorised by the Community". The requirements of the Member States related to the so called "Blue Box" have been updated. Requirements for the new Member States
Updating the Notice to Applicants - Volume 2A Chapter 7 "General Information"
DG Enterprises releases an updated version of Chapter 7 "General Information" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation including information for applications made in the CTD format.
The European Court of Justice rules on the compatibility with Community law of national legislation prohibiting import of medicinal products by way of mail orders placed by consumers over the internet.
In a ruling handed down on 11 December 2003, the ECJ has concluded that national legislation prohibiting import of medicinal products by way of mail order to pharmacies approved in other Member States in response to individual orders placed by consumers over the internet is a measure having equivalent effect within the meaning of Article 28 EC as regards medicinal products authorised in the country of importation. The prohibition has a greater impact on pharmacies established outside the Member State of importation and may impede access to the market for products from other Member States more than it impedes access for domestic products. According to the ECJ, such a measure having equivalent effect can be justified under Article 30 EC on public health grounds as regards prescription medicines, but not as regards non-prescription medicines.
Moreover, the ECJ has considered that a prohibition of national law on advertising the sale by mail order of medicinal products is lawful as regards products not authorised in the Member State concerned as well as prescription medicines, since such prohibitions follow from Articles 87(1) and 88(1) of Directive 2001/83/EC. For medicinal products falling outside these categories, the prohibition is a violation of Article 88 of the mentioned Directive, which allows medicinal products not subject to prescription to be advertised to the general public.
NOTICE TO APPLICANTS VOLUME 2C and 6C REGULATORY GUIDELINES Application form for renewal of a marketing authorisation
Updating the Notice to Applicants Volume 2C and 6C Regulatory Guidelines: Application form for renewal of a marketing authorisation for human medicinal products and veterinary medicinal products.
The main changes are then updating of the directive references to Directive 2001/83/EC and 2001/82/EC and the alignment of the section on manufacturers with the current Part IA form.
Application Form (Word 97 format)Application Form .pdf format)