Pharmaceuticals Archives - 2003

18/12/03

European Court of First Instance clarifies the conditions for the admissibility of an application for annulment of a CPMP opinion and the conditions for the admissibility of an application for annulment of a Commission decision.
In its judgment of 18 December 2003, the European Court of First Instance has ruled, in case T-326/99 ("Nancy Fern Olivieri against Commission of the European Communities and European Agency for the Evaluation of Medicinal products"), that the opinion of the CPMP is an intermediate measure whose purpose is to prepare for the marketing authorisation decision: it is is a preparatory measure which does not definitively lay down the Commission's position and therefore it is not challengeable act. The Court has therefore declared the application for annulment of the CPMP opinion inadmissible. Concerning the conditions for the admissibility of an application for annulment of a Commission decision, the Court of First Instance has examined, among other aspects, whether the applicant had in this case entitlement to challenge, in an action for annulment, the scientific evaluation made by the CPMP and confirmed by the Commission decision.. The Court has declared that Regulation 2306/93 establishes a pure bilateral procedure between the applicant for marketing autorisation and the administration. In this case, Dr Olivieri, in her capacity as third party in the marketing authorisation procedure, was not entitled to participate in that procedure.

18/12/03

The Commission publishes a reflection paper on control of residues of veterinary medicinal products and Maximum Residue Limits.pdf(236 KB)
DG Enterprise and DG Health and Consumer Protection have reflected on several current issues connected to the Community legislation on residues of veterinary medicinal products in food. This discussion paper presents points that need to be considered and debated with a view to reassess and modify the legislation to better serve the needs of all stake holders in this sector. The goal is to determine new means to balance consumer protection, animal health and welfare as well as trade requirements concerning residues of pharmacologically active substances used in veterinary medicinal products in food producing animals.
On the basis of the comments and suggestions received, the Commission will present a proposal for new legislation both on the evaluation of residues of pharmacologically active substances and their control in food. Please provide your comments no later than 20 March 2004 to the e-mailbox comments-mrlpaper@ec.europa.eu or in writing to Mr. Philippe Brunet, Head of Unit DG Enterprise F2 and Mrs. Patricia Brunko, Head of Unit D3, DG Health and Consumer Protection, European Commission, Rue de la Loi 200, B-1049, Brussels, Belgium.NB: The above document contains hyperlinks (in the text and the footnotes) to the reference documents. All these documents have been made available in .pdf format on this site. Note that these hyperlinks can only be used when an active internet connection is available.

18/12/03

Today (17/12/2003) the European Parliament has adopted the compromise amendments negotiated with the Council on the Pharmaceutical Review package. This paves the way for its adoption in the beginning of next year. Attached you will find the speech Commissioner Liikanen gave before the European Parliament Plenary on 16/12/2003pdf(70 KB)

15/12/03

"On going Stability - Addition to Chapter 6 to the EU Guide to Good Manufacturing Practice"pdf(80 KB)
The additional text "On going Stability" for Chapter 6 to the EU GMP Guide has been adopted by the Ad hoc GMP inspectors Working Group at their meeting in October 2003. The proposed text provides guidance on ongoing stability monitoring thereby clarifying that ongoing stability monitoring is a Community GMP expectation in line with the GMP requirements of our MRA partners. The Pharmaceutical Committee has endorsed the proposal through written procedure. The document is released for a consultation period until 15 June 2004. Comments should be sent to GMP@emea.eu.int and in parallel to Karin.Krauss@ec.europa.eu.

15/12/03

"Product Quality Review - Addition to Chapter 1 to the EU Guide to Good Manufacturing Practice"pdf(100 KB)
The additional text "Product Quality Review" for Chapter 1 to the EU GMP Guide has been adopted by the Ad hoc GMP inspectors Working Group at their meeting in July 2003. The proposal arises from the experience of Member States' inspectorates where quality problems with products on the market leading to recall could have been anticipated if the manufacturer/marketing authorisation holder had operated a system for formally reviewing process consistency and trends. The Pharmaceutical Committee has endorsed the proposal through written procedure. The document is released for a consultation period until 15 June 2004. Comments should be sent to GMP@emea.eu.int and in parallel to Karin.Krauss@ec.europa.eu.

21/11/03

Outcome of the Workshop on Human Pandemic Influenza Vaccine
The Workshop on Human Pandemic Influenza was held on November 6th, 2003, gathering all the stakeholders (Member States, WHO, Industry, EDQM, Scientific Experts, EMEA and European Commission). The main goals were:
- to define a Community strategy in case of a pandemic influenza situation, addressing the availability of an authorised "pandemic influenza vaccine",
- to draw up explicit written scientific and procedural guidance on what should be done in advance in order to tackle such a pandemic situation when it occurs.

All details from this first Workshop can be found here.

17/11/03

European Court of Justice clarifies the conditions for the application of the abridged procedure for generic medicinal productspdf(127 KB)
In its judgment of 16 October 2003, the European Court of Justice has ruled on the interpretation of point 8(a)(iii) of the third paragraph of Article 4 of Directive 65/65 (now Article 10(1)(a)(iii) of Directive 2001/83/EC on the Community code relating to medicinal products for human use), concerning the conditions for the application of the abridged procedure for the granting of marketing authorisations to generic medicinal products. The Court has ruled that the requirement, contained in that provision, that the reference product "is marketed in the Member State for which the application is made" must be understood as referring to a medicinal product which has been granted a marketing authorisation in the Member State concerned. It is not necessary for the reference product to have actually been placed on the market of that member State . Additionally, according to the Court it is necessary and sufficient that the marketing authorisation of the reference medicinal product be in force in the Member State concerned on the date of the application for a marketing authorisation of the generic medicinal product.

03/11/03

Updated version of Chapter 7 General information in volume 6A Notice to Applicants October 2003pdf
Chapter 7 of the Notice to Applicants Volume 6A has been updated as concerns change of addresses of the Belgian, Swedish and Norwegian competent authorities. A reminder has been included regarding the necessity to submit for centralised marketing authorisation applications, separate applications to the competent authorities in the EFTA countries Iceland, Norway and Liechtenstein.

27/10/03

Updating the Notice to Applicants Volume 2C and 6C Regulatory Guidelines
Guideline on the categorisation of Extension Application (EA) versus Variations Applications (V)
Medicinal products for human and veterinary use
- The Guideline on the categorisation of Extension Applications (EA) versus Variations Applications (V)pdf(300 KB) has been updated in order to take account of the revised Regulations on variations (Regulation (EC) No 1084/2003 and Regulation (EC) No 1085/2003). This Guideline is part of the "Notice to applicants" Volume 2C - Regulatory Guidelines - of "The Rules governing Medicinal Products in the European Union".
- The Guideline on the categorisation of Extension Applications (EA) versus Variations Applications (V)pdf has been updated in order to take account of the revised Regulations on variations (Regulation (EC) No 1084/2003 and Regulation (EC) No 1085/2003). This Guideline is part of the "Notice to applicants" Volume 6C - Regulatory Guidelines - of "The Rules governing Medicinal Products in the European Union".

27/10/03

Updated version of Volume 6B Notice to applicants (October 2003)
This version of Volume 6B has been updated to take into account new legal references and information required in the dossier.

27/10/03

Updated version of Part 1A Administrative data in Part 1 of Volume 6B Notice to Applicants October 2003
The updated version of Part 1 A Administrative data in Part 1 of Volume 6B Notice to Applicants is supplied in Word format. This application format should be used for applications for marketing authorisations for veterinary medicinal products in the European Union.
- Updated version - October 2003 (PDF format - Word Format)

27/10/03

Guideline on the packaging information of veterinary medicinal products authorised by the Community - revision 2 (blue box) (October 2003)
This Guideline has been updated to provide for specific information required by national authorities of Member States, EFTA states and accession countries to be indicated in the labelling and package insert for veterinary medicinal products authorised by the Community

27/10/03

Commission Directive 2003/94/ECpdf(118 KB) , of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.

24/10/03

The Council adopted the common positions on the proposal for Regulation modifying Council Regulation 2309/93 on the centralised procedure and the EMEA and on the proposals modifying Directive 2001/83/EC establishing a Community code on medicinal products for human use and Directive 2001/82/EC establishing a Community code on veterinary medicinal products. Belgium and Netherlands voted against the common positions of the Regulation and the directive modifying Directive 2001/83/EC ("human code"). Germany abstained on the common position of the Regulation. The common position of the directive modifying Directive 2001/82/EC ("veterinary code") was adopted by unanimity.

10949/03pdf(323 KB)10950/03pdf(274 KB)10951/03pdf(287 KB)

01/10/03

New Guideline on the dossier requirements for type IA and type IB notifications for minor variations to the terms of marketing authorisations in the mutual recognition and the centralised procedure. The new Guideline on dossier requirements for type IA and IB notifications for variations to the terms of marketing authorisations granted following the mutual recognition procedure or the centralised procedure. It contains in an convenient format both the conditions applicable to these types of variations in accordance with the new Commission Regulations (EC) No 1084/2003 and (EC) No 1085/2003 and the corresponding dossier requirements to be fulfilled. This Guideline replaces the previous guidance in Volume 2C and 6C of the Notice to Applicants for medicinal products for human use and veterinary medicinal products.

29/09/03

The proposal modifying Regulation 2309/93 on the centralised procedure was adopted by the Council on 18 June 2003 and published on 29 September 2003 on the Official Journal. The modification concerns the provisions of the Regulation on the EMEA budget procedure, on the tasks of the executive Director and the Management Board of the EMEA and on the application of Regulation 1049/2001 concerning the access to documents of the Community institutions to the documents of the EMEA.

16/09/03

EU - EMEA - FDA Confidentiality agreement letterspdf(3 MB)
The European Commission, the European Agency for the Evaluation of Medicinal Products (EMEA) and the US Food and Drug Administration (FDA) announced on 12 September 2003 that they have concluded a confidentiality agreement.

- EU - EMEA - FDA Confidentiality agreement letterspdf(3 MB)
- Public Statement Choose translations of the previous link  (ps)

05/09/03

Study on the price of orphan medicinal products.
This service contract will cover a "Study on the price of orphan medicinal products". The aim of the study is to propose methods for assessing the price of orphan medicinal products.
The call for tender was published on the 26th of August 2003 in the OJEU S 2003 /.162-148407 dated 26/08/2003; electronic copies can be found here; paper copies can be requested at the following address: patrick.accart@ec.europa.eu.
The deadline for submission is 20/10/2003

12/08/03

Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2B
Presentation and content of the dossier - Part 1: Summary of the dossier - Part 1A - 1998 edition
or
Common Technical Document - Module 1 - Administrative information: application form - 2001 edition

Application Formmsw8: The application form is updated in section 2.5.1.2 Batch control / Testing arrangements and section 2.5.3. Manufacturer(s) of the active substance
User Guide for the Application Formpdf: The application form is updated in section 2.5.1.2 Batch control / Testing arrangements and section 2.5.3. Manufacturer(s) of the active substance

01/08/03

Commission Communication on Regulation (EC) No 141/2000 on orphan medicinal products
Following the first three years of application of the Regulation on orphan medicinal products, the Commission has issued a Communication which sets out a position on certain matters relating to the implementation of the designation and market exclusivity provisions. This has been done in response to requests for interpretation and clarification.
The Communication is intended to provide guidance to the European Medicines Evaluation Agency, the Member States, the pharmaceutical industry and other interested parties.
The Communication considers points in relation to:
- Article 3 (criteria for designation)
- Article 5 (procedure for designation and removal from the Community register on orphan medicinal products)
- Article 7 ( Community marketing authorisation)
In addition, the Commission is obliged to draw up detailed guidelines on the application of Article 8 of Regulation (EC) No 141/2000. This obligation is met in part by section D on market exclusivity (Article 8) in the Communication.
The Communication is published in the Official Journal of the European Union C 178, 29.07.2003, p. 2.

01/08/03

New application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure.
The new application form for variations to a marketing authorisation should be used from 1 October 2003 and is in accordance with the new Commission Regulations (EC) No 1084/2003 and (EC) No 1085/2003. This application form is self-explanatory and replaces the previous application forms in Volume 2C and 6C of the Notice to Applicants for medicinal products for human use and veterinary medicinal products. The previous explanatory note on how to fill in the form is therefore redundant and will be deleted.
- Application Form (Word 97 format)pdf
- Application Form .pdf format)pdf

25/07/03

Telematics
During the last Telematic Steering Committee (9 July 2003, Verona), the new modified version of the implementation plan of the EU telematic strategy was agreed.

25/07/03

UPDATING THE NOTICE TO APPLICANTS Volume 3B (C7A)
DG Enterprises releases an updated version of the guideline 'Excipients in the Label and Package Leaflet of Medicinal Products for Human Usepdf'.

25/07/03

UPDATING THE NOTICE TO APPLICANTS Volume 4
DG Enterprises releases an updated version of Annex 13 of the Guide to Good Manufacturing Practice For Medicinal Productspdf.
Annex 13 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to investigational medicinal products. The revision takes account of the requirements of Articles 13 and 14 of Directive 2001/20/EC as well as the experience of industry and regulators with the existing annex.

24/07/03

Court of Justice confirms judgment of 26.11.2002 concerning medicinal products containing certain anorectic substances
Today, the Court of Justice announced its judgment dismissing the Commission's appeal against the Court of First Instance judgment of 26.11.2002. The Engish text of the judgmentpdf(143 KB) as well as a brief note on the consequencespdf(113 KB) is available.

23/07/03

Maximum Residue Limits of veterinary medicinal products in foodstuffs of animal origin
A new consolidated version of the Annexes I to IV of Council Regulation n°2377/90 Updated on 22.07.2003 is now available in all official EU languages here

18/07/03

New Guideline on the dossier requirements for type IA and type IB notifications for minor variations to the terms of marketing authorisations in the mutual recognition and the centralised procedurepdf
The new Guideline on dossier requirements for type IA and IB notifications for variations to the terms of marketing authorisations granted following the mutual recognition procedure or the centralised procedure. It contains in an convenient format both the conditions applicable to these types of variations in accordance with the new Commission Regulations (EC) No 1084/2003 and (EC) No 1085/2003 and the corresponding dossier requirements to be fulfilled. This Guideline replaces the previous guidance in Volume 2C and 6C of the Notice to Applicants for medicinal products for human use and veterinary medicinal products.

08/07/03

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/82/EC on the Community code relating to veterinary medicinal productspdf(260 KB)

07/07/03

"Classification of Teat Dip spdf(17 KB)spdf(17 KB) " - Outcome of the joint session meeting of 12th June 2003 between the Veterinary Pharmaceutical Committee and the Competent Authorities of Member States for the directive on Biocidal products (Dir.98/8/EC): endorsement of the guidance document Doc-Biocides 2003/01-12.06.03 on Borderline products between Directive 98/8/EC concerning the placing on the market of biocidal products and Directive 92/46/EC concerning raw mil, heated milk, and milk products

07/07/03

Guideline on the processing of renewals in the mutual recognition procedure for veterinary medicinal products
The guideline on the processing of renewals of marketing authorisations for veterinary medicinal products in the mutual recognition procedurepdf has been updated to take into account legal references to Directive 2001/82/EC

27/06/03

NOTICE TO APPLICANTS, VOLUME 2B, COMMON TECHNICAL DOCUMENT (CTD) A revised version of the CTD (Introduction, Module 1, 2, 3, 4 and 5) is available.
The edition July 2003 is an update of the CTD in order to include some Guidelines published since the publication of the previous version. All references to the old format are deleted.
The format of the CTD is now mandatory for all new applications and variations submitted in the centralised procedure to the EMEA. According to the agreement in the NtA group it is also highly recommended to submit national applications and variations to the competent authorities in the Member States in CTD format.

A revised version of the "Questions and answers" document related to the CTD is available.
The revision concerns the questions relating to the "European Drug Master Files (EDMF).

27/06/03

New Annex I to 2001/83 and new variation regulations
The new Annex I to Directive 2001/83/EC as well as the two new regulations on variations (Regulations (EC) No 1084/2003 and No 1085/2003) have been published in the Official Journal L 159 of 27.6.2003.

26/06/03

Review of the Pharmaceutical Legislation
On the 2nd of June 2003, the Health Council adopted a political agreement on the proposal for Regulation modifying Council Regulation 2309/93 on the centralised procedure and the EMEA and on the proposal modifying Directive 2001/83/EC establishing a Community code on medicinal products for human use.

Amended proposal for a Regulation of the European Parliament and of 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 Productspdf(307 KB)

Amended proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human usepdf(257 KB)

26/06/03

Veterinary Pharmaceutical Committee - Information on the outcome of the 13th meetingpdf(137 KB) (19 September 2002)

24/6/03

Volume 8 has been updated with respect to legal references and references to other Notes for guidance
Volume 8 of The Rules governing Medicinal Products in the European Union. Notice to applicants and Note for guidance for the establishment of maximum residue limits (MRLs) for residues of veterinary medicinal products in foodstuffs of animal originpdf has been updated with respect to legal references and references to other Notes for guidance. It provides information on the operational procedure for applications for the establishment of MRL's, provides guidance on the presentation and content of the application dossier. It also provides information on how the safety and residue data are evaluated and describes the assessment process.

20/6/03

Pharmaceutical Committee - Summary Record of the 54rd meeting 13th November 2002pdf(116 KB)

20/6/03

Pharmaceutical Committee - Summary Record of the 53rd meeting 14th May 2002pdf(105 KB)

20/6/03

European Court of Justice rules that the Republic of Finland has failed to fulfil its obligations under Article 6 of Directive 89/105/EECpdf(112 KB)
In its judgment of 12 June 2003, the European Court of Justice has ruled that the Republic of Finland has failed to fulfil its obligations under Directive 89/105/EEC (the so-called "Transparency Directive", which applies to any national measure to control the prices of medicinal products for human use or to restrict the range of medicinal products covered by the national sickness insurance systems). In particular, decisions adopted pursuant to the Finnish legislation as to the inclusion of a medicinal product in a category qualifying for higher-rate insurance cover did not comply with the requirements of Article 6 of the directive, since they were not amenable to judicial review and they did not have to contain a statement of reasons, nor did the persons concerned have a right to be heard.

03/6/03

COMMISSION REGULATION (EC) No …/..of […]
concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No. 2309/93
This Regulation will be published in the Official Journal in a fortnight.

03/6/03

COMMISSION REGULATION (EC) No …/..of […]
concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State
This Regulation will be published in the Official Journal in a fortnight.

03/6/03

The EU Health Ministers reached on Monday 2, June 2003, a political agreement with qualified majority on the proposals by the European Commission on the review of the pharmaceutical legislationpdf(67 KB) . The political agreement concerns only the Regulation on the centralised procedure and the European Medicines Evaluation Agency and the Directive modifying Directive 2001/83/EC on human medicines. The Directive modifying Directive 2001/82/EC on veterinary medicines will now be finalised in the working group of the Council.

03/6/03

Revision of Annex 1 (Manufacture of sterile medicinal products) to the EU GMP Guide (Volume 4)pdf
The revision of Annex 1 to the EU GMP Guide has been adopted by the Ad hoc GMP inspectors Working Group at their meeting on 28-29 April 2003. The amendments only concern section 3 harmonising where appropriate 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) together with a minor change to section 20. The remainder of the annex is unchanged. The Pharmaceutical Committee has adopted the revised version at its meeting on 15 May 2003 fixing 1 September 2003 as date for coming into operation.

27/5/03

Update of the List of substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90pdf(71 KB)
The list of substances, prepared by the CVMP, which are considered not falling within the scope of the MRL Regulation, has been updated to include diethanolamine in concentrations up tp 0.3 mg/kg/day

16/5/03

2nd Announcement for ICH6
New Horizons and Future Challenges
November 12-15 2003, Osaka, Japan

13/5/03

EMEA/CPMP Guidance document on use of medicinal products for the treatment of patients exposed to terrorist attacks with chemical agentspdf(151 KB)
At the request of the European Commission, (the Pharmaceuticals Unit, Enterprise DG) the EMEA and its Scientific Committee, the Committee for Proprietary Medicinal Products (CPMP) have produced a guidance document on the use of medicinal products for the treatment of patients exposed to terrorist attacks with chemical agents.

13/5/03

Study concerning part of the extended impact assessment of the Commission proposal for legislation on medicinal products for paediatric use.
An extended impact assessment of the Commission proposal for legislation on medicinal products for paediatric use must be performed before the proposal is adopted by the Commission. Part of the impact assessment is being put out to tender. The call for tender was published on the 8th of May 2003 in the OJEU 2003/S 89-079163; paper copies can be requested at the following address: patrick.accart@ec.europa.eu. The deadline for submission is 17/06/2003

6/5/03

Study on innovation in the pharmaceutical area
In 2002 the European Agency for the Evaluation of Medicinal Products, which is in charge of this centralised procedure, noted that there was a significant drop in the number of applications for marketing authorisations concerning new chemical entities. In order to identify what lies at the root of this phenomenon, to measure its actual size and to propose measures to halt it, the Commission has decided to launch a study to answer the following questions:- Is there a worldwide crisis in innovation in the pharmaceutical sector?
- What are the reasons behind this crisis?
- What tools do we have available to kick-start innovation? The call for tender was published on the 3rd of May 2003 in the OJEU 2003/S 86-076424; electronic copies can be found here; paper copies can be requested at the following address : patrick.accart@ec.europa.eu. The deadline for submission is 03/06/2003

25/4/03

Protocols to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECAs): Key Elements of GMP Sector
From today, a table concerning the key elements of the GMP sector of the "Protocols to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECAs)" and the 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 countries" are available in a new section "PECA" of F2 unit activities.

23/4/03

Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human usepdf(173 KB)
DG Enterprises releases the: 'Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use' as required by Article 18 of Directive 2001/20/EC.The detailed guidance will be included in the Notice to Applicants in the new Volume 10 relating to information on clinical trials.

23/4/03

Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module)pdf(189 KB)
DG Enterprises releases the: 'Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module)' as required by Article 11, Article 17 and Article 18 of Directive 2001/20/EC.

The detailed guidance will be included in the Notice to Applicants in the new Volume 10 relating to information on clinical trials.

23/4/03

Detailed guidance on the European clinical trials database (EUDRACT Database)pdf(208 KB)
DG Enterprises releases the: 'Detailed guidance on the European clinical trials database (EUDRACT Database) ' as required by Article 11 and Article 17 of Directive 2001/20/EC.

The detailed guidance will be included in the Notice to Applicants in the new Volume 10 relating to information on clinical trials.

23/4/03

Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human usepdf(178 KB)
DG Enterprises releases the: 'Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use' as required by Article 8 of Directive 2001/20/EC.

The detailed guidance will be included in the Notice to Applicants in the new Volume 10 relating to information on clinical trials.

23/4/03

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trialpdf(294 KB)
DG Enterprises releases the: 'Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial' as required by Article 9 (8) of Directive 2001/20/EC.

The detailed guidance will be included in the Notice to Applicants in the new Volume 10 relating to
information on clinical trials.

14/4/03

Updated version of Chapter 4 Centralised Procedures in volume 6A Notice to Applicants April 2003pdf
A new version of chapter 4 (Centralised procedures) has been agreed in the Working Party on the Notice to Applicants. The chapters describe the procedures in detail and should provide useful guidance to applicants, including regime for supply of translations of the product literature.

14/4/03

Updated version of Chapter 7 General Information in volume 6A Notice to Applicants April 2003pdf
Updated tables on general requirements for submission of applications for marketing authorisation for veterinary medicinal products

09/4/03

Commission adopts modified proposal on traditional herbal medicines
On 9 April 2003, the Commission has adopted the amended proposal for a Directive on traditional herbal medicinal products. The Commission reacts on some amendments suggested by the European Parliament in its vote of November 2002. As compared to the original proposal, the amended text brings changes in particular with regard to the scope of the simplified procedure, to the minimum time of use within the EU and to the competences of the new scientific committee for herbal medicines. The modified proposal is available in all linguistic versions below.

04/4/03

Mutual Recognition Agreements (MRAs): update on current status, key elements and product coverage of GMP sector
From today, regularly updated versions of the "Current status of Mutual Recognition Agreements - GMP sector" and of a table "Mutual Recognition Agreements - Key Elements and Product Coverage (GMP sector) are available in F2 unit activities (section "Mutual Recognition Agreements").

02/4/03

MRA EU-Switzerland, chapter 15 on medicinal products GMP and batch certification;
revised "explanatory notes"
The Agreement between the European Community and the Swiss confederation on mutual recognition Choose translations of the previous link chamoru (ch) 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) .New documents agreed by the Joint Committee have been published in the Official Journal as follows:
Decision No 1/2003 (2003/128/EC) in OJ L 56, 01.03.2003, p. 1-213
Corrigendum to Decision No 1/2003 (2003/128/EC) in OJ L 66, 11.03.2003, p. 51
Decision No 2/2003 (2003/154/2003) in OJ L 68, 12.03.2003, p. 1-39 (including chapter 15)
All language versions are available on http://europa.eu/eur-lex .The actual versions of the Internationally Harmonised Requirements for Batch Certification and the EU Certificate of GMP Compliance of a manufacturer are available on the EMEA website http://www.emea.europa.eu/htms/technical/mra/mra.htm .

25/3/03

Notice to Applicants, Volume 2b, Common Technical Document (CTD)pdf
A revised version of the "Questions and answers" document related to the CTD is available.
The revision concerns:
- an update of the question 2 - reformatting of dossiers; question 4 - variations; question 6 - line extensions; questions 7 and 8 - generic applications; question 9 - herbal medicinal products; question 10 - Mutual Recognition and question 13 - bibliographic applications.

25/3/03

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 edition
The application form is updated in section 2.5.3 definition of final manufacturer and section 2.6.2 with the request to include the number of the certificate of suitability for TSE.
Pdf formatpdf - Word formatmsw8

18/3/03

Operational phase of the EU-Canada Mutual Recognition Agreement entered into force on 1 February 2003.
The Sectoral Annex on Good Manufacturing Practice started its operational phase on 1 February 2003. The Joint Sectoral Group met on 17 January 2003 and agreed that the transitional activities should end. The Joint Committee was informed and recorded at its 6th meeting on 13 March 2003 that this sector is operational now. The list of products covered under the Annex includes human and veterinary medicinal products. Veterinary immunological products are not included. The Annex is not in operation for pre-approval inspections and stable medicinal products derived from human blood or human plasma. The agreement is based on exchange of certificates of GMP compliance for manufacturers and batch certificates. The contents of these certificates are agreed and available on the EMEA website. The two-way alert system is in operation.

10/3/03

"Qualifizierung und Validierung" Choose translations of the previous link Deutsch (de)
The document is the German version of the Annex 15 to the EU GMP Guide with title "Qualification and Validation". The updated version has been provided by Germany (ZLG) and has been agreed by the German "Länder", the German Health Ministry, the German Working Group "Medicinal Gases" and also the Austrian Authorities. Germany has asked us to add this updated version and to remove the old DE version from our website.
EudraLex Volume 4 - Medicinal products for human and veterinary use : Good manufacturing practices

10/3/03

"Zertifizierung durch eine sachkundige Person und Chargenfreigabe"pdf
The document is the German version of the Annex 16 to the EU GMP Guide with title "Certification by a Qualified person and Batch Release". The version has been provided by Germany (ZLG) and has been agreed by the German "Länder", the German Health Ministry, the German Working Group on "Inspections" and also the Austrian Authorities. Germany has asked us to add this version to the versions (EN, EL, ES, FR, IT, NL) already published on our website.
EudraLex Volume 4 - Medicinal products for human and veterinary use : Good manufacturing practices

10/3/03

"Parametrische Freigabe" Choose translations of the previous link Deutsch (de)
The document is the German version of the Annex 17 to the EU GMP Guide with title "Parametric Release". The version has been provided by Germany (ZLG) and has been agreed by the German "Länder", the German Health Ministry, the German Working Group on "Inspections" and also the Austrian Authorities. Germany has asked us to add this version to the versions (EN, ES, FR, IT, NL) already published on our website.
EudraLex Volume 4 - Medicinal products for human and veterinary use : Good manufacturing practices

14/2/03

New directive on human blood and blood components entered into force
On 8 February 2003, the new directive on quality and safety standards of human blood and blood components entered into force. The full title is Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, published in the Official Journal L 33 of 8 February 2003, p. 30. This directive is relevant for the pharmaceutical sector, as it lays down technical requirements for the collection and testing of all blood and blood components including starting materials for medicinal products. In this context, it amends Article 109 of Directive 2001/83 (see Article 31 of Directive 2002/98). The text of Directive 2002/98/EC is available in all linguistic versions below.

13/2/03

The Commission lodged an appeal against the Court of First Instance judgement of 26 November 2002 in Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00, T-137/00 and T-141/00pdf(247 KB) concerning the withdrawal of marketing authorisations for medicinal products containing certain anorectic substances. The appeal has been assigned the number C-39/03 P. The Commission asked for a decision on the appeal through an expedited procedure. In addition, the Commission has asked the Court of Justice to suspend the effects of the judgement delivered by the Court of First Instance.

11/2/03

The Standing Committees on medicinal products for human use and on veterinary medicinal products issued, in the meeting of 10 February 2003, a favourable opinion by qualified majority to the adoption by the Commission of a draft Commission Regulation amending Council Regulation (EC) n° 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products.
The Regulation will modify the amount of the fees by increasing all fees, except the annual fee, by 16%. The annual fee is adjusted by 26%.
The Regulation is being finalised and will be submitted to the Commission for final adoption soon. The new Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.
(Table containing the new amount of feespdf(55 KB) )

5/2/03

DG Enterprise releases an updated version of Chapter 7 "General Information" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisationpdf including information for applications made in the CTD format

5/2/03

NOTICE TO APPLICANTS, VOLUME 2B, COMMON TECHNICAL DOCUMENT (CTD)
A revised version of the "Questions and answerspdf(314 KB)" document related to the CTD is available.
The revision concerns:
- an update of the question 11 concerning "Mutual Recognition"
- new questions: question 15 concerning "European Drug Master Files (EDMF) - format" and question 16 concerning "European Drug Master File and variations".

15/1/03

The Committee for Proprietary Medicinal Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP) during their December 2002 meetings have endorsed the revised Note for Guidance (NfG) on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products, EMEA/410/01pdf(272 KB) Rev. 2. By virtue of Annex I to Directives 2001/82/EC and 2001/83/EC this NfG is mandatory. The revised document is now published on the Web site of the Commission for a three-month external consultation.