Pharmaceuticals Archives - 2002

12/12/02

Review of the pharmaceutical legislation: Commission modified proposal for the Regulationpdf(252 KB)danskDeutschελληνικάespañolfrançaisitalianoNederlandsportuguêssuomisvenska
After the first reading of the European Parliament, the Commission has adopted the modified proposal of the "regulation of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products"

12/12/02

Court of First Instance supports that centrally authorised medicines should generally bear one single trade namepdf(160 KB)
In its judgement of 10 December 2002, the Court of First Instance annulled the decision of 1st March 2000, that had refused to vary the name and package layout of a centrally authorised medicine. The reason for the annulment is that the decision was not sufficiently motivated. On the merits, the Court states that the letter and spirit of Regulation 2309/93 suggests that a Community marketing authorisation will contain as a general rule only one name. That name can be varied by adding another name only where the marketing authorisation holder demonstrates that this is rendered necessary by exceptional circumstances which may adversely affect public health and where the Commission has ascertained that the variation applied for satisfies the criteria of the quality, safety and efficacy of the medicinal product. (Judgement of the Court of First Instance in Case T-123/00 "Karl Thomae" of 10 December 2002)pdf(160 KB)

10/12/02

DG Enterprise releases an updated version of Chapter 4 "Centralised Procedure" of the Notice to Applicants on Medicinal Productspdf on the procedures for marketing authorisation following the adoption of the Community Code relating to medicinal products for human use (2001/83/EC of the European Parliament and of the Council) in force since 18 December 2001.
Legal references have been taken account of and no other changes have been introduced.
(EudraLex Vol 2)

03/12/02

Updated version of Chapter 6 Decision making procedure of Volume 6A Notice to Applicants December 2002pdf
DG Enterprise is releasing a revised version of Chapter 6 dealing with the "Decision Making Procedure".
The old version included additional information, which has been already published as guidelines in Volume 6C.
This document is part of the "Notice to applicants - Volume 6A -Veterinary medicinal products - Procedures for marketing authorisation - Chapter 6: Decision Making Procedure" of "The Rules governing Medicinal Products in the European Union".
(EudraLex Vol 6)

03/12/02

Updated version of Part 1A Administrative data in Part 1 of Volume 6B Notice to Applicants December 2002pdf
An updated version of Part 1 A Administrative data in Part 1 of Volume 6B Notice to Applicants has been produced with a possibility to use the tick-boxes in the form. A number of minor administrative changes have also been introduced. This application format should be used for applications for marketing authorisations for veterinary medicinal products in the European Union.
Pdf formatpdf - Word formatmsw8
(EudraLex Vol 6)

22/11/02

Updating the "Notice to Applicants" Volume 2A
Chapter 1 "Marketing Authorisation"pdf
DG Enterprises releases an up dated version of Chapter 1 "Marketing Authorisation" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation following the adoption of the Community Code relating to medicinal products for human use (2001/83/EC of the European Parliament and of the Council) in force since 18 December 2001.
Legal references have been taken account of and no other changes have been introduced.

22/11/02

Updating the "Notice to applicants" Volume 2A
Chapter 2 "Mutual Recognition"pdf
DG Enterprises releases an up dated version of Chapter 2 "Mutual Recognition" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation following the adoption of the Community Code relating to medicinal products for human use (2001/83/EC of the European Parliament and of the Council) in force since 18 December 2001.
Legal references have been taken account of and no other changes have been introduced.

22/11/02

Updating the "Notice to applicants" Volume 2A
Chapter 3 "Community Referral"pdf
DG Enterprises releases an up dated version of Chapter 3 "Community Referral" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation following the adoption of the Community Code relating to medicinal products for human use (2001/83/EC of the European Parliament and of the Council) in force since 18 December 2001.
Legal references have been taken account of and no other changes have been introduced.

20/11/02

Consultation on a new proposal for a revision of Annex 1 (Manufacture of sterile medicinal products) to the EU GMP Guide (Volume 4)pdf(122 KB)
The new proposal for a revision of Annex 1 to the EU GMP Guide has been adopted by GMP inspectors at their meeting on 23 October 2002. The amendments have primarily been introduced to harmonise the environmental standards for clean rooms laid down in the GMP Guide with those laid down in international standards (e.g. EN/ISO 14644-1). The Pharmaceutical Committee has endorsed the proposal at its meeting on 13 November 2002. The document is released for a consultation period until 10 January 2003.
Comments should be sent in parallel to GMP@emea.eu.int and to Karin.Krauss@ec.europa.eu

13/11/02

The Agreement between the European Community and the Swiss confederation Choose translations of the previous link chamoru (ch) on mutual recognition in relation to conformity assessment entered into force on 1st June 2002. Chapter 15 of this agreement concerns medicinal products GMP inspection and batch certification and allows for the mutual recognition of the results of GMP inspections performed in the EU and Switzerland. As of 1st June 2002, imports of medicinal products into the EU from Switzerland are not required to be recontrolled at import provided they are imported in accordance with the provisions of chapter 15.The legal references of the "explanatory notes" on the operation of this chapter have been revised by the European Commission and the Swiss authorities in October 2002pdf(88 KB) Models for the Internationally Harmonised Requirements for Batch Certificationpdf(124 KB) [word formatmsw8(438 KB) ] and an EU Certificatepdf(146 KB) [word formatmsw8(445 KB) ] of GMP Compliance of a manufacturer are also provided."

14/10/02

First revision and update of guideline on format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another.pdf(156 KB)
Following the end of the comment period, and in accordance with Article 5. 3 of Regulation 141/2000 on orphan medicinal products a first revision and update of the format and contents guideline is now available.
[Word Formatmsw8(117 KB) ] - .pdf Formatpdf(156 KB) ]

12/09/02

Updating the Notice to Applicants- Medicinal Products for Human Use-Volume 2A - Procedures for marketing authorisation
Chapter 6: Decision Making Procedurepdf
DG Enterprise is releasing a revised version of Chapter 6 dealing only with the "Decision Making Procedure".
The old version included additional information which has been already published as guidelines in Volume 2C.
This document is part of the "Notice to applicants - Volume 2A - Medicinal Products for Human Use - Procedures for marketing authorisation - Chapter 6: Decision Making Procedure" of "The Rules governing Medicinal Products in the European Union".

02/09/02

Notice to applicants, Volume 2B, Common Technical Document (CTD)
A revised version of the "Questions and answers" document related to the CTD is availablepdf.
The revision concerns:
- an update of the question 12 concerning "Certificates of suitability"
- new questions: question 13 concerning "Bibliographical applications" and question 14 concerning "European Drug Master File".
This document is part of the "Notice to applicants - Medicinal Products for Human Use - Volume 2B

27/08/02

DG Enterprise publishes an update of the inventory of national and community measures supporting research into and availability of orphan medicinal products.pdf(230 KB)
The Regulation on Orphan Medicinal Products adopted in 2000 requires Member States to communicate to the Commission detailed information concerning any measure that have enacted to support research into, and the development and availability of, orphan medicinal products or medicinal products that may be designated as such. On the basis of this information, the Commission prepared and published on 1 January 2001 a first detailed inventory of all incentives made available by the Community and the Member States to support research into and availability of orphan medicinal products, thus meeting its obligations according to the regulation. This inventory has been updated for the first time.

27/08/02

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 Communitypdf
DG Enterprise publishes an updated version of the "Guideline on the packaging information of human medicinal products authorised by the Community". This Guideline is part of the "Notice to applicants" Volume 2C - Regulatory Guidelines" of "The Rules governing Medicinal Products in the European Union". The revised version with legal references in accordance with the Community Code relating to medicinal products for human use (Directive 2001/83/EC) has been prepared by the Notice to Applicants Working Party. The requirements of the Member States related to the so called "Blue Box" have been updated. The revised version also clarifies the issue relating to the mentioning of local representatives in the labelling and the leaflet.
Volume 2C - Medicinal products for Human Use - Regulatory Guidelines

22/08/02

Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2B
Presentation and content of the dossier-Part 1: Summary of the dossier-Part1A-1998 edition
or
Common Technical Document-Module 1-Administrative information: application form-2001 editionUser Guide for the Application FormpdfIn order to aid the applicants in the completion of the application form, a user guide has been prepared by the Notice to Applicants Working Party.
This document is part of the "Notice to applicants - Medicinal Products for Human Use - Volume 2B - Part 1 or Module 1 of "The Rules governing Medicinal Products in the European Union".

30/07/02

EMEA/CPMP Guidance document on use of medicinal products for treatment and prophylaxis of biological agents that might be used as weapons of bioterrorismpdf(307 KB) Last Update: 25 July 2002

17/07/02

Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2B
Presentation and content of the dossier-Part 1: Summary of the dossier-Part1A-1998 edition or CommonTechnical Document-Module 1-Administrative information: application form-2001 edition.
The application form prepared by the Notice to Applicants Working Party has been updated in accordance with Directive 2001/83/EC.
This document is part of the "Notice to applicants - Medicinal Products for Human Use - Volume 2B - Part 1 or Module 1 of "The Rules governing Medicinal Products in the European Union".

12/07/02

Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance -Clinical Trial Module)pdf(155 KB)

12/07/02

Detailed Guidelines on the principles of good clinical practice in the conduct in the EU of clinical trials on medicinal products for human use Draft 5.1pdf(134 KB)

12/07/02

Detailed guidance on the application format and documentation to be submitted in an application for an ethics committee opinion on a clinical trial on a medicinal product for human use Draft 5.2pdf(254 KB)

12/07/02

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities in the European Union, notification of substantial amendments and declaration of the end of a clinical trial. Draft 6pdf(242 KB)

12/07/02

Detailed guidance on the European clinical trials database (EUDRACT Database)pdf(358 KB)

12/07/02

Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human usepdf(241 KB)

04/07/02

CONSULTATION ON THE NEED FOR A COMMUNITY LEGAL FRAMEWORK ON "HUMAN TISSUE ENGINEERED PRODUCTS"
Tissue engineering is a new and rapidly developing technology that intends to produce viable substitutes that restore, maintain or improve the function of human tissues or organs. It differs from standard therapies by the fact that the engineered products become integrated within the patient, affording a potentially permanent and specific cure of the disease, injury or impairment. It is an inter disciplinary field that applies the principles of biology and engineering.
It is important to establish a clear regulatory framework for this area.
The attached consultation document invites contributions on the need and contents of such a framework.

01/07/02

At the request of the European Commission, Enterprise DG, the Pharmaceuticals Unit, the EMEA and its Scientific Committee, the Committee for Proprietary Medicinal Products (CPMP) produced a guidance document Note for guidance on the development of vaccinia virus based vaccines against smallpoxpdf(219 KB) . This Note for Guidance will be updated as further experience is gained in the development and manufacture of second generation smallpox vaccines.

24/06/02

EudraLex Volume 1: Pharmaceutical legislation : Medicinal Products for Human Use
Database of updated EC legislation on human medicinal products. Further linguistic versions under preparation.

24/06/02

The guidelines on the summary of product characteristics for pharmaceutical and immunological veterinary medicinal products have been updated to conform with Directive 2001/82/EC of the European Parliament and of the Council on the Community Code relating to veterinary medicinal products. The SPC guideline for immunological products now contains recommendations on statements for products containing mineral oil adjuvants.
DG Enterprise publishes the revised Guidelines on the Summary of Product Characteristics for pharmaceutical and immunological veterinary medicinal products in Volume 6C Regulatory Guidelines of the Notice to Applicants for Veterinary Medicinal Products in "The rules governing medicinal products in the European Union". The only major changes include alignment of legal references with Community legislation in force and an updated section 5.12 on recommended statements for immunolgical products containing mineral oil adjuvants.
- Guideline Summary of the Product Characteristics SPC - Pharmaceuticals revision 1pdf
- Guideline Summary of the Product Characteristics SPC - Immunologicals revision 1pdf

21/06/02

The guideline on the processing of renewals of marketing authorisations for veterinary medicinal products authorised by the Community is now included in Volume 6C Regulatory Guidelines Notice to Applicants for Veterinary Medicinal Productspdf DG Enterprise publishes the Guideline on the processing of renewals of marketing authorisations for veterinary medicinal products authorised by the Community in Volume 6C Regulatory Guidelines of the Notice to Applicants for Veterinary Medicinal Products in "The rules governing medicinal products in the European Union". This guideline is identical to the guideline on renewals in the centralised procedure available at the web-site of the European Medicines Evaluation Agency (EMEA).

21/06/02

Overview of comments on consultation paper "Better Medicines for Children"

14/06/02

DETAILED GUIDELINES ON THE TRIAL MASTER FILE AND ARCHIVINGpdf(142 KB) to implement the directive on Clinical Trials on medicinal products for human use.
Following discussion within the Good Clinical Practice inspectors' working party (Ad Hoc Meeting of GCP Inspection Services) detailed guidelines are proposed as required by article 15.5 of the Directive 2001/20/EC for the master file on the trialand archiving.
The draft proposals are released for a 3 month consultation period.

14/06/02

DETAILED GUIDELINES ON THE QUALIFICATIONS OF INSPECTORS WHO SHOULD VERIFY COMPLIANCE IN CLINICAL TRIALS WITH THE PROVISIONS OF GOOD CLINICAL PRACTICE FOR AN INVESTIGATIONAL MEDICINAL PRODUCTpdf(145 KB) to implement the directive on Clinical Trials on medicinal products for human use.
Following discussion within the Good Clinical Practice inspectors' working party (Ad Hoc Meeting of GCP Inspection Services) detailed guidelines are proposed as required by article 15.5 of the Directive 2001/20/EC on the qualification of inspectors (GCP)
The draft proposals are released for a 3 month consultation period.

14/06/02

DETAILED GUIDELINES ON INSPECTION PROCEDURES FOR THE VERIFICATION OF GCP COMPLIANCEpdf(203 KB) to implement the directive on Clinical Trials on medicinal products for human use.
Following discussion within the Good Clinical Practice inspectors' working party (Ad Hoc Meeting of GCP Inspection Services) detailed guidelines are proposed as required by article 15.5 of the Directive 2001/20/EC on inspection procedures (GCP)
The draft proposals are released for a 3 month consultation period.

22/05/02

Notice to Applicants, Volume 2B, Common Technical Document (CTD)
A revised version of the CTD is available.
The revision concerns:
an update of the Annexes to Module 3, Module 4 and Module 5 in order to include some Guidelines published since the publication of the previous version. For the Annex to Module 3, the new Guidelines marked with an * will be included in Module 3 itself when the Module is next updated, as they are specifically cited in the Module. For the Annex to Module 4 and the Annex to Module 5, the new Guidelines are marked with an *.

15/05/02

Notice to Applicants, Volume 2B, Common Technical Document (CTD) QUESTIONS AND ANSWERS The document called "QUESTIONS AND ANSWERS" has been completed with 11 new questions and answers. This document has been prepared in order to help the implementation of the CTD in the EU form on administrative perspective. It concerns only regulatory or administrative questions. It will be regularly completed with new questions and answers.

02/05/02

Modifications to Commission Directive 91/356 of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use, as required by Directive 2001/20/ECpdf(105 KB)
Following discussion within the working parties on medicinal products and inspections (Good manufacturing practices and Good clinical practices sectors) modifications to Commission Directive 91/356 are proposed to incorporate the principles and guidelines of good manufacturing practice for investigational medicinal products referred to in Article 13.3 and in the requirements for a manufacturing authorisation referred to in Article 13.1 of the Directive on Good Clinical Practice.
The draft proposal is released for a 3 months consultation period.pdf(105 KB)
Two column informal working documentpdf(138 KB)

30/04/02

Working document on the future revision of Annex I : Analytical, Pharmacotoxicological and Clinical Standards and Protocols in respect of the testing of Medicinal Productspdf(435 KB) to Directive 2001/83/EC
The working document is now published on the Web site to give the opportunity to all of the interested parties to express their own views on the proposed provisions. The final deadline for this external consultation is Monday 17 June 2002.
Working documentpdf(435 KB) - Explanatory notepdf(101 KB)

24/04/02

Commission Directive on the requirements to obtain an authorisation to manufacture or import an investigational medicinal product and the requirements to be met by the holder of this authorisation to implement the directive on Clinical Trials on medicinal products for human use.
Following discussion within the working parties on medicinal products and inspections (Good manufacturing practices and Good clinical practices sectors) a Commission directive is proposed setting out the requirements to obtain an authorisation to manufacture or import an investigational medicinal product and the requirements to be met by the holder of this authorisation. This fulfils requirements set out in article 13.1 of Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trails on medicinal products for human use.
The draft proposal is released for a 3 months consultation period.pdf(110 KB)

24/04/02

Detailed guidelines on the community basic format and the contents of the application for a manufacturing and/or import authorisation of an investigational medicinal product for human use to implement the directive on Clinical Trials on medicinal products for human use.
Following discussion within the working parties on medicinal products and inspections (Good manufacturing practices and Good clinical practices sectors) detailed guidelines are proposed setting out the community basic format and the contents of the application for an authorisation to manufacture or import an investigational medicinal product as provided for in Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trails on medicinal products for human use.
The draft proposal is released for a 3 months consultation period.pdf(202 KB)

21/04/02

EudraLex Volume 4 : Medicinal products for human and veterinary use : Good manufacturing practices
DE, ES, FR, IT, NL versions of annexes 6, 15, 16, 17 are available

12/04/02

Publication of Guidance Document on the Implications of the Operational phase of the GMP annexes to the Protocol to the European agreement on Conformity assessment and Acceptance of industrial products (PECA) with European Union associated countriespdf(213 KB)
Following the entry into force of the GMP and Batch certification annex of the PECA agreements with Hungary on 1st December 2001 and Czech Republic on 1st January 2002, the Commission has prepared a document which aims to describe and provide guidance on the key activities which should be undertaken by industry and regulators in the EU
and in an associated country with which a PECA concerning Good Manufacturing Practice (GMP) has entered into force. The content of the manufacturer's certificate of compliance and the batch certificate which must be prepared by the company are described.

12/04/02

Final version of guideline on format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another.pdf(181 KB)
Following the end of the comment period, and in accordance with Article 5. 3 of Regulation 141/2000 on orphan medicinal products a final version of the format and contents guideline is now available.
The annex to this guideline is available in a downloadable form. [PDF Formatpdf(217 KB) ] [Word formatmsw8(85 KB) ]

03/04/02

EMEA/CPMP Guidance document on use of medicinal products for treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism (Revision 2)pdf(410 KB)
At the request of the European Commission, Enterprise DG, the Pharmaceuticals Unit, the EMEA and its Scientific Committee, the Committee for Proprietary Medicinal Products (CPMP) produced a guidance document on the use of medicinal products for treatment and prophylaxis of biological agents, that might be used as weapons of bioterrorism. The first version of the guidance, produced on 16th January 2002, considered those agents in Category A of the US Centre for Disease Control's (CDC) list of agents that might be used for the purposes of bioterrorism. On 21 February 2002 the document was extended to cover agents in categories B and C of the CDC's list.

05/03/02

Review of Pharmaceutical legislation : Updated "two column working documents" availlable
From today, updated versions of the" two column working documents" are available in English and French. To facilitate the ongoing discussion on the Review, these documents set out the changes proposed by the Commission in an easy legible format. The updated versions are based on the final proposals as transmitted to the European Parliament and the Council on 26 November 2001 and replace the preliminary versions, which had been published on 26 July 2001. The two column texts are informal documents only and without prejudice to the official proposal (COM(2001)404 final).

28/02/02

Better medicines for children - proposed regulatory actions on paediatric medicinal productspdf(169 KB)
Ideas for ensuring children they get the medicines they need, and in the right doses, are set out in a consultation paperpdf(169 KB) published today and launched by Commissioner Liikanen. The paper lists the objectives that any new rules aiming to remedy the shortage of child-specific medicines should meet, and suggests ways to attain them. These include incentive measures, regulatory requirements and research funding suggestions. The need for greater transparency and expert regulatory and clinical supervision is also highlighted. To get the best and safest treatments for children across Europe, society must strike the right balance between incentives and regulatory obligations. Before a formal regulatory proposal is defined, interested parties are invited to comment on the suggested measures with the aim of ensuring that both existing and new medicines are adapted to paediatric needs in the most resource-efficient manner for society as whole. A press releasepdf(78 KB) and overview documentpdf(80 KB) are also available.
Comments on the consultation paper should be sent by e-mail to entr-paed-consultation@ec.europa.eu or by mail to
European Commission
DG ENTERPRISE
Unit F/2 - Paediatric initiative
To the attention of Emer Cooke
Rue d'Arlon 88, 1/56
B - 1049 - Brussels
Deadline: 30th April 2002

28/02/02

EMEA/CPMP Guidance document on use of medicinal products for treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism (Revision 1)pdf(531 KB)
At the request of the European Commission, Enterprise DG, the Pharmaceuticals Unit, the EMEA and its Scientific Committee, the Committee for Proprietary Medicinal Products (CPMP) produced a guidance document on the use of medicinal products for treatment and prophylaxis of biological agents, that might be used as weapons of bioterrorism. The first version of the guidance, produced on 16th January 2002, considered those agents in Category A of the US Centre for Disease Control's (CDC) list of agents that might be used for the purposes of bioterrorism. On 21 February 2002 the document was extended to cover agents in categories B and C of the CDC's list.

19/02/02

Updated versions of Chapters 1, 2 and 3 in volume 6A Notice to Applicants February 2002 DG Enterprise releases updated versions of Chapters 1, 2 and 3 of the Notice to Applicants for Veterinary Medicinal Products on the procedures for marketing authorisation, mutual recognition and community referrals following the adoption of the Community Code relating to veterinary medicinal products (Directive 2001/82/EC of the European Parliament and of the Council) in force since 18 December 2001. The new legal references have been taken account of and no other changes have been introduced.

01/02/02

Updated version of Part 1A Administrative data in Part 1 of Volume 6B Notice to Applicants January 2002
An updated version of Part 1 A Administrative data in Part 1 of Volume 6B Notice to Applicants has been produced following the adoption of the Community Code for veterinary medicinal products (Directive 2001/82/EC, OJ L 311, 28.11.2001, p. 1). This application format should be used for applications for marketing authorisations for veterinary medicinal products in the European Union.

23/01/02

Updated version of Guideline on the packaging information of veterinary medicinal products authorised by the Community in volume 6C Regulatory Guidelines Notice to Applicants for Veterinary Medicinal Productspdf DG Enterprise publishes an updated version of the Guideline on the packaging information of veterinary medicinal products authorised by the Community in Volume 6C Regulatory Guidelines of the Notice to Applicants for Veterinary Medicinal Products in "The rules governing medicinal products in the European Union".
The revised version with legal references in accordance with the Community Code relating to veterinary medicinal products (Directive 2001/82/EC) has been prepared jointly by the EMEA Secretariat and the Notice to Applicants Working Party. It is based on the experience from operating the centralised procedure. The revised guideline also clarifies the issue relating to the mentioning of local representatives in the package insert.
Volume 6C - Veterinary medicinal products -Regulatory guidelines

18/01/02

Veterinary Pharmaceutical Committee - Final summary record of the 11th meeting - 1 June 2001pdf(133 KB)

17/01/02

Commission adopts proposal for a Directive on traditional herbal medicinal products
The Commission adopted today the proposal for a Directive on traditional herbal medicinal products. It provides for a simplified registration procedure for herbal medicinal products with a traditional medicinal use of at least 30 years. The quality standards are the same like in the regular authorisation procedure. The tests and trials on safety and efficacy of the products can be replaced by information on the traditional use of the product where this provides a sufficient basis for its assessment. The procedure ensures that only medicinal products complying with the requirements of quality, safety and efficacy may be marketed in the Europen Union and contributes to the full protection of public health. The proposal also foresees a new scientific committee to be established in the EMEA, which shall in particular establish monographs on herbal medicinal products. The proposal will be sent to the European Parliament and the Council soon.