Implementing texts for Directive 2001/20/EC

12/04/05

COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 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 the manufacturing or importation of such products
The European Commission published in the Official Journal of 9 April 2005 the COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 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 the manufacturing or importation of such products
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 January 2006 at the latest.

26/04/04

Detailed guidance on the European clinical trials database (EUDRACT Database)
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,
CT 5.1 Amendment describing the development of EudraCT Lot 1 for 1 May 2004 and CT 5.2 EudraCT core dataset.

26/04/04

Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use
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 revision 1.

26/04/04

Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module)
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 revision 1.

26/04/04

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
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 revision 1.

26/04/04

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
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 revision 1.

23/4/03

Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module)
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)
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 use
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 trial
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.

12/07/02

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

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 5.1

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 5.2

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 6

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

Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use

04/06/02

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/EC

Two column informal working document

DETAILED GUIDELINES ON THE TRIAL MASTER FILE AND ARCHIVING to implement the directive on Clinical Trials on medicinal products for human use.

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 PRODUCT to implement the directive on Clinical Trials on medicinal products for human use.

DETAILED GUIDELINES ON INSPECTION PROCEDURES FOR THE VERIFICATION OF GCP COMPLIANCE to implement the directive on Clinical Trials on medicinal products for human use.

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.

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.

Revision of Good Manufacturing Practices annex 13 to implement directive on Clinical Trials on medicinal products for human use.