Marketing Authorisation Application procedures
in the Eurasian Economic Union

Online-training, March, 23 / March, 30 *
The training will be held twice: on March 23 and 30.
Choose the most convenient date for you.

Training program
March, 23 / March, 30
11:00 - 15:00 (CEST, GMT+1)
1. Documents founding the Single EAEU pharmaceutical market
Similarity and dissimilarity with the EU documents
2. Main procedures
Marketing authorization: mutual recognition procedure and decentralized procedure

Harmonisation procedure

Abbreviated MAA procedures

Orphan designation

Variation procedures

3. Local requirements
Local clinical trials

Local GMP

Local Pharmacopoeia

The normative document

Pre-authorisation lab testing

Product information: PL user testing
4. EAEU regulatory classification of applications and medicinal products
New/stand-alone applications

Extension applications

Generics, hybrids, biosimilars

Combination products, well-established use, informed consent, mixed MAAs

Radiopharmaceuticals, blood products, vaccines

Herbal and homeopathic products
5. Communication between national competent authorities of the Member States during procedures and related problems
IT-communication problems

Personal communication problems

Ravil Niyazov
Regulatory Affairs and Drug Development Specialist
Center for Scientific Advice Ltd.
Regulatory affairs and drug development consultant. Main focus on early and intermediate development. Cross-sectional topics such as quality/non-clinical, non-clinical/clinical, manufacturing/clinical, development and regulatory strategies
1 participant from the company - 300 Euro
2 participants - 450 Euro
3 participants - 600 Euro
4 participants - 750 Euro
Our clients:
Ukraine: +38 044 300 25 17
Kazakhstan: +7 727 310 20 82

[email protected]
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