After an authorization has been issued in accordance with the respective regulation, based on new experiences the person responsible for placing a medicinal product on the market has to ensure and to adopt continuously quality, safety and efficacy of the product.
With respect to the methods of production and control provided for as set out in Article 8 of Directive 2001/83/EC, the MAH has to consider any technical and scientific progress and shall make any amendments that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods.
As an authorization does not affect the civil and criminal liability (2001/83/EC, Art. 25) the MAH has forthwith to inform all relevant competent authorities of any safety relevant information which might entail an amendment of the respective documents, for instance the approved summary of product characteristics. Any prohibition or restriction imposed by the competent authorities of any country has to be communicated which might influence the evaluation of the benefits and risks of the medicinal product concerned. The aforementioned person has to apply for approval for these amendments in accordance with the respective Regulation.