Richtlijn 1991/412 - Vastlegging van beginselen en richtsnoeren inzake goede praktijken bij het vervaardigen van geneesmiddelen voor diergeneeskundig gebruik - Hoofdinhoud

SUMMARY OF:

Commission Directive 91/412/EEC — good manufacturing practice for veterinary medicines

SUMMARY

WHAT DOES THIS DIRECTIVE DO?

It sets out the principles and guidelines of good manufacturing practice for medicines for animal use.

KEY POINTS

National authorities must organise regular inspections to ensure manufacturers comply with the principles and guidelines set out in the legislation.

Manufacturers must:

ensure that their activities are properly authorised and respect good manufacturing practice;

regularly review their manufacturing methods in the light of scientific and technical progress;

establish and implement an effective pharmaceutical quality assurance system, involving management and staff;

have enough competent and qualified staff to ensure quality standards are met;

define the duties of the managerial and supervisory staff and provide them with appropriate training;

establish and maintain documentation records, a quality control system under a suitably qualified person and hygiene programmes;

conduct frequent inspections of their operations and take any necessary corrective measures;

implement a system to respond to, and investigate, complaints and have measures in place to promptly recall any medicines if necessary, while informing the competent authorities of their action.

The premises and equipment used must be located, designed, constructed, adapted and maintained to suit their intended purpose, minimise the risk of error and allow effective cleaning and maintenance.

The quality control system includes access to quality control laboratories and must retain samples of each batch of medicines for at least a year after their expiry date.

Any work contracted out must be authorised by a written contract setting out the responsibilities of both parties in complying with good manufacturing practice.

Importers must ensure that the imported products have been manufactured according to standards that are at least equivalent to those in the EU.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 23 July 1991. EU countries had to incorporate it into national law by 23 July 1993.

BACKGROUND

For more information, see:

‘Quality of medicines and Good Manufacturing Practices (GMP)’ on the European Commission’s website

‘Good-manufacturing-practice and good-distribution-practice compliance’ on the European Medicines Agency’s website

ACT

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, pp. 70–73)

RELATED ACTS

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33).

Subsequent amendments to Regulation (EC) No 726/2004 have been incorporated into the basic text. This consolidated version is of documentary value only.

Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, pp. 58–84)

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 (OJ L 311, 28.11.2001, pp. 1–66). See consolidated version.

last update 19.04.2016

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