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.

Program
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

Renewal
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

Quasi-eCTD
Speaker
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
Registration
Price:
1 participant from the company - 300 Euro
2 participants - 450 Euro
3 participants - 600 Euro
4 participants - 750 Euro
Our clients:
Contacts:
Phones:
Ukraine: +38 044 300 25 17
Kazakhstan: +7 727 310 20 82

E-mail:
[email protected]
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