№ lp_1_2_21170
Form for documenting submission of final translations of veterinary product information, including Member States’ comments, implementation status, and checklist compliance for annex files.
Note: Year
Region / City: European Union
Subject: Veterinary medicinal product translations
Document type: Regulatory submission form
Organization: European Medicines Agency (EMA)
Author: Applicant / Marketing Authorisation Holder (MAH)
Target audience: MAHs, EU Member States authorities
Deadline for comments: Specified per procedure
Submission type: Post-opinion review, Day +25 final submission
Attachments: Annex I (SPC), Annex II, Annex IIIA (labelling), Annex IIIB (package leaflet)
Language coverage: All EU languages
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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