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Medicines

Manufacturers, distributors and importers of medicines intended for human use must hold a Manufacturing or Wholesale Authorisation. The Inspectorate enforces this legal obligation in the Netherlands.

All other European member states have a similar agency charged with this task and the Inspectorate cooperates closely with them. Supervision applies to both registered drugs and those currently undergoing clinical trials.

The inspections are primarily concerned with compliance of the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines. Manufacturers based in countries outside the European Union are also subject to inspection on the authority of the European Medicines Agency (EMEA) and the Dutch Medicines Evaluation Board (CBG).

In addition to the overall status, these inspections assess individual products for compliance with the terms and conditions of their (European) marketing authorisation. The Inspectorate also conducts GMP inspections of the manufacturers of veterinary medicines, doing so in association with the relevant department of the Medicines Evaluation Board. Licensing for manufacturers is governed by the terms of the Veterinary Medicines Act.

Applications for Manufacturing or Wholesale Authorisations should be submitted to Farmatec (www.farmatec.nl). If the Inspectorate finds that a manufacturer is indeed complying with the GMP guidelines, it will issue a GMP certificate. The Inspectorate also advises the Minister of Health on issuing or revising Manufacturing or Wholesale Authorisations.

On request, the Inspectorate will also advise the Medicines Evaluation Board regarding licensed manufacturers (for the purposes of 'site clearance'). The manufacturers of the active pharmaceutical ingredients do not need a Manufacturing Authorisation. Nevertheless, GMP inspections of these companies will be conducted at the request of the EMEA, CBG, EDQM or the manufacturers themselves.

Reporting side effects

If you experience any unexpected side-effects from a registered medicine, you should report them to https://www.lareb.nl/Meld-bijwerking/Meldformulier.aspx (Netherlands Pharmacovigilance Centre).

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