What is RMS and CMS?
The Member State that has already authorised the product is known as the Reference Member State ( RMS ). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member States ( CMS ).
What is a Type Ia variation?
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.
What is a MA holder?
MA Holder means the entity that holds the Marketing Approval for a product in a given country.
What is dossier submission?
The dossier submission – a selection of documents and data that sums up the entire story of how a company’s product developed and evolved. Based on the dossier, the product will gain marketing approval – or not.
What are type IB variations?
A minor change to a marketing authorisation that the marketing-authorisation holder must notify to the regulatory authority before implementation, but which does not require formal approval. For more information, see type IB variations: questions and answers.
What is MAA in regulatory?
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
What was the purpose of Directive 2001 / 83 / EC?
Whereas of Directive 2004/27/EC: . (1) 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, codified and consolidated in a single text the texts of Community legislation on medicinal products for human use, in the interests
What was the European Parliament directive of 2001?
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.
What was the community code of 2001 / 83 / EC?
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. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
When was the Directive on medicinal products for human use amended?
Amended by Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46-94). Corrigendum (OJ L 302, 20.11.2003, p. 40, DE).