Notice to applicants

Notice to Applicants (NTA) has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Agency for the Evaluation of Medicinal Products.

The Notice to Applicants is prepared by the Commission in accordance with article 6 of Regulation (EEC) No. 2309/93 and Directive 2001/82/EC and 2001/83/EC.

It is important when reading this text to appreciate that the legal requirements of the Directives and the Regulations must be met and that this Notice presents the harmonised views of the Member States and the European Agency for the Evaluation of Medicinal Products on how those requirements may be met.

NTA - human medicinal products

The Notice to Applicants for human medicinal products (Volume 2 in the series The Rules Governing Medicinal Products in the European Union) is presented in three parts:

Icon: New Window Volume 2A dealing with procedures for marketing authorisation.

Icon: New Window Volume 2B dealing with the presentation and content of the application dossier.

Icon: New Window Volume 2C dealing with regulatory guidelines.

NTA - veterinary medicinal products

The Notice to Applicants for veterinary medicinal products (Volume 6 in the series The Rules Governing Medicinal Products in the European Union) is presented in three parts;

Icon: New Window Volume 6A dealing with procedures for marketing authorisation.

Icon: New Window Volume 6B dealing with the presentation and content of the application dossier.

Icon: New Window Volume 6C dealing with regulatory guidelines.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information