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Regulatory Guidance

24.04.2017
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The Notice to Applicants is prepared by the European Commission to give the harmonised views how the legal requirements of the Directives and Regulations may be met.

Human medicines

Veterinary medicines

The State Agency of Medicines has prepared guidance papers to facilitate the authorisation process and to give the necessary contact points for different questions.

Guidance for submission of documents

eSubmissions

Requirements for signatures

Guidance for submission of product information

Guideline for the naming of medicinal products

Pharmaceutical terminology

Additional risk minimisation measures (aRMM) - Submission of educational materials

CMDh position paper on the use of the QR codes and Annex 2: Applicant’s declaration