For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities refer to the detailed guidelines referred to in Article 27a of Directive 81/851/EEC.

whereas, if clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and OECD Guidelines for Good Clinical Practice;

The CVMP/ 627/ 01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.

encouraging the development of evidence-based guidelines for good clinical practice and improved public health strategies by accelerating the translation of existing research results into applications.

The manufacturing process shall comply with the requirements of Commission Directive 91/356/EEC laying down the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use(2) and with the principles and guidelines on GMP, published by the Commission in The rules governing medicinal products in the European Community, Volume 4.

in Article 47, the following paragraphs shall be added:"The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines.

Commission Directive 2003/94/EC 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

in Article 51, the following paragraphs shall be added:"The principles of good manufacturing practice as regards the manufacturing of active substances for use as starting materials as referred to in Article 50(f) shall be adopted in the form of detailed guidelines.

Whereas all veterinary medicinal products manufactured or imported into the Community, including medicinal products intended for export should be manufactured in accordance with the principles and guidelines of good manufacturing practice;

Whereas the detailed guidelines mentioned in Article 27a of Directive 81/851/EEC have been published by the Commission after consultation with the pharmaceutical inspection services of the Member States in the form of a "Guide to good manufacturing practice for medicinal products";

All medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of good manufacturing practice.

Where one or more Member States, or the Commission, consider that, for the purposes of harmonization, there may be a need for guides to good hygiene practice to be developed on a European basis (hereafter referred to as 'European guides to good hygiene practice'), the Commission shall consult Member States in the framework of the Standing Committee on Foodstuffs in accordance with Article 14.

These detailed guidelines are published by the Commission in the "Guide to good manufacturing practice for medicinal products" and in its annexes (Office for Official Publications of the European Communities, The Rules Governing Medicinal Products in the European Community, Volume IV).

Labelling of the investigational medicinal products intended for trials of this nature should be subject to simplified provisions laid down in the good manufacturing practice guidelines on investigational products and in Directive 91/356/EEC.

Most of these methods are developed within the framework of the OECD programme for Testing Guidelines, and should be performed in conformity with the principles of Good Laboratory Practice, in order to ensure as wide as possible "mutual acceptance of data".

Commission Directive 2003/94/EC 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(2) is to be incorporated into the Agreement.

Detailed guidance on the elements to be taken into account when evaluating products with the object of releasing batches within the Community shall be drawn up pursuant to the good manufacturing practice guidelines, and in particular Annex 13 to the said guidelines.

When not taken from regulatory standards (e.g. frozen storage temperature) or from existing and validated guides of good manufactoring practices, the team should ascertain their validity relative to the control of identified hazard and critical points.

For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the "Guide to good manufacturing practice for medicinal products and for investigational medicinal products".

This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the authorisation referred to in Article 13 of Directive 2001/20/EC.

After obtaining the opinions of the Member States in the Standing Veterinary Committee, the Commission may, if it deems necessary, draw up recommendations containing guidelines on good manufacturing practices applicable at the different stages of the production and placing on the market of the products referred to in Article 1.

Article 13(3) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(4) requires that detailed guidance be drawn up, in accordance with the guidelines on good manufacturing practice, on the elements to be taken into account when evaluating investigational medicinal products for human use with the object of releasing batches within the Community.

Such assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance and mobilising and coordinating investigation teams.

Priority will be given to developing principles and guidelines for best practice on the prudent use of antimicrobial agents in human medicine together with competent authorities and to activities that foster education and intervention programmes aimed at the health professionals and hospitals to combat antimicrobial resistance.

The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47.

The particulars to appear in at least the official language(s) of the Member State on the outer packaging of investigational medicinal products or, where there is no outer packaging, on the immediate packaging, shall be published by the Commission in the good manufacturing practice guidelines on investigational medicinal products adopted in accordance with Article 19a of Directive 75/319/EEC.

in the case of investigational medicinal products manufactured in the Member State concerned, that each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use(12), the product specification file and the information notified pursuant to Article 9(2) of this Directive;

The object of the Codex Alimentarius Commission is, inter alia, to develop and harmonise world-wide health standards and to issue guidelines and recommendations on agricultural and fishery products, foodstuffs, food additives and contaminants, feedstuffs, veterinary drugs, pesticides, including labelling, methods of analysis and sampling, codes of ethics and good agricultural practice and guidelines of hygiene practice, in view of protecting consumers' health and ensuring fair practices in international trade.

The Agency ’ s inspection-related working parties will: harmonise inspection procedures and processes, in particular those relating to inspections of active substances and to pharmacovigilance; develop guidelines in light of the requirements of Community legislation on clinical trials and blood; and continue to work on GMP guidelines on products used as gene and cell therapies.

The CVMP concluded that the production of Bovilis BVD vaccine is in compliance with GMP requirements, that extraneous agent testing of raw materials are carried out according to the relevant requirements and that extraneous agent testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs.

As a general rule, the European Community has exclusive competence for agenda items dealing with harmonisation of standards on certain agricultural products, foodstuffs, food additives, contaminants, veterinary drug, pesticides, fish and fishery products, including labelling, methods of analysis and sampling, as well as codes and guidelines of hygiene practice, insofar as the Community legislation has harmonised either completely or to a large extent the relevant fields in these areas, as well as issues of international trade to the extent that they are related to the objectives of the Codex Alimentarius Commission, notably to protecting the health of the consumers and ensuring fair practices in the food trade.