Guidance for the template for the qualified person’s …
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-template-qualified-persons-declaration-concerning-good-manufacturing-practice-gmp_en.pdf
compliance of active substance manufacture “The QP declaration template” EMA/196292/2014 Page 3/8 3. Application of the QP declaration The QP declaration applies to all human and veterinary medicinal products. A QP declaration is required to be submitted with all applications for new marketing authorisations,
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