Medicinali e dispositivi veterinari

Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use

Sono stati approvati, in aggiornamento di EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use - Volume 6C - Regulatory Guidelines: 

il nuovo APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION

• http://esubmission.emea.europa.eu/eaf/eaf_9.1/variation_v1.9.1.pdf   
• http://ec.europa.eu/health/files/eudralex/vol-2/c/variation_form__201307_en.pdf

ed il nuovo  APPLICATION FORM FOR RENEWAL OF A MARKETING AUTHORISATION

• http://ec.europa.eu/health/files/eudralex/vol-2/c/appl_form_renewal_2013_07_en.pdf
• http://esubmission.emea.europa.eu/eaf/docs/renewal_v1.6.1.pdf

Data di pubblicazione: 12 luglio 2013 , ultimo aggiornamento 6 novembre 2013

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