Medicines and investigational medicines for human use — safe production

SUMMARY OF:

Commission Directive 2003/94/EC — good manufacturing practice for medicines and investigational medicines for human use

SUMMARY

WHAT DOES THE DIRECTIVE DO?

It sets out the principles and guidelines of good manufacturing practice for medicines and investigational medicines* for human use.

KEY POINTS

• National authorities must organise 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 action;
  • 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 documentation system must contain details of each batch of products and kept for at least a year after their expiry date for medicines; and for investigational medicines, at least 5 years after the end of the clinical trial in which they were used. Electronic data must be protected against any loss or damage.
• Different production operations must comply with pre-established instructions and procedures.
• The quality control system includes access to quality control laboratories and must retain samples of each batch of products for at least a year after their expiry date for medicines; and for investigational medicines, at least 2 years after the end of the clinical trial in which they were used.
• 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 imported products have been manufactured according to standards that are at least equivalent to those in the EU.
• Separate legislation (Regulation (EU) No 536/2014) sets out the conditions that clinical trials must meet.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 3 November 2003. EU countries had to incorporate it into national law by 30 April 2004.

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

KEY TERM

* Investigational medicine: a pharmaceutical form of an active substance or placebo that is being tested or used as a reference in a clinical trial.

ACT

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 (OJ L 262, 14.10.2003, pp. 22–26)

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 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, pp. 34–57)

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67–128). See consolidated version.

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1–76)

last update 19.04.2016