List of steps
Total number of steps : 3
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2Application for the licensing of pharmaceuticals production
Contact details
Additional informationNeeded documents include:
-copies of articles of association; -state duty payment receipt; (a) list of medicines to be produced; (b) documents on technologies assuring the quality of the products; (c) copies of documents certifying producer`s ownership (or other legal cause allowing operation) of premises and facilities; <>(d) copies of documents authorizing the legal entity to operate premises and facilities (or production facilities only) owned by other companies producing pharmaceuticals (agreements, contracts, certificates, etc.); (e) copies of sanitary and epidemiological inspection report certifying conformity of potential production with sanitary regulations; (f) copies of documents (diplomas, certificates, etc) certifying that qualifications of persons involved in production, quality assurance and marking of products meet the licensing requirements. Copies not certified by a notary need attachment of originals. |