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Summaries of EU Legislation

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EU rules on the authorisation, import and production of medicines for humans

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EU rules on the authorisation, import and production of medicines for humans

Medicines for human use must satisfy strict authorisation procedures to prove they meet high quality and safety standards. Different national provisions must also be removed to ensure they are available throughout the European Union (EU).

ACT

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

SUMMARY

WHAT DOES THE CODE DO?

It brings together all the existing provisions in force on the sale, production, labelling, classification, distribution and advertising of medicinal products for human use in the EU.

KEY POINTS

  • All medicines offered for sale in the EU must have prior authorisation from either a national authority or the European Medicines Agency.
  • To receive the authorisation, manufacturers must provide a range of detailed therapeutic information about the product, including any possible side-effects.
  • Authorisation may be refused if a medicine’s risk-benefit ratio is not considered favourable or its therapeutic effect is insufficiently substantiated.
  • National authorities should make every effort to complete the authorisation procedure within 210 days from the submission of a valid application. Authorisation is valid for 5 years and is renewable.
  • A mutual recognition procedure exists to enable medicines already authorised in 1 EU country to be sold in another.
  • The legislation sets out in detail the information, such as storage precautions, expiry date and batch number, which must be given on the outer packaging.
  • Medicines are classified according to whether they require a medical prescription or not.
  • Strict controls are laid down for advertising medical products to the general public. The information must be presented objectively, not exaggerate an item’s properties and not be misleading.
  • National pharmacovigilance systems* are in place to collect information, particularly on adverse reactions in human beings, potentially useful for monitoring medicinal products.
  • Specific provisions apply to homeopathic products*. These may be subject to a simplified registration procedure if they are taken orally or applied externally.
  • The legislation does not apply to whole blood, plasma or certain medicinal products, such as those prepared in a pharmacy or used for research and development.
  • The European Commission has also issued guidelines for good practices in the manufacture and distribution of medicinal products.

WHEN DOES THE DIRECTIVE APPLY?

From 18 December 2001.

For more information, see the medicinal products for human use page of the European Commission’s website.

KEY TERMS

* Pharmacovigilance systems: systems set in place to monitor the effects of medicines and, in particular, to identify and assess adverse reactions.

* Homeopathic products: remedies based on the idea that the body has the ability to heal itself, i.e. a substance that causes the symptoms of a disease in healthy people can cure similar symptoms in sick people.

REFERENCES

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2001/83/EC

18.12.2001

-

OJ L 311 of 28.11.2001, pp. 67-128

Successive amendments and corrections to Directive 2001/83/EC have been incorporated into the basic text. This consolidated version is for information only.

RELATED ACTS

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 (Official Journal L 262 of 14.10.2003, pp. 22-26).

Guidelines of 5 November 2013 on good distribution practice of medicinal products for human use (Official Journal C 343 of 23.11.2013, pp. 1-14)

Guidelines of 19 March 2015 on principles of good distribution practice of active substances for medicinal products for human use (Official Journal C 95 of 21.3.2015, pp. 1-9).

Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (Official Journal C 95 of 21.3.2015, pp. 10-13).

last update 06.08.2015

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