Medicinali e dispositivi veterinari

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Procedure

In order to request the registration of the distribution of active substances used as starting materials in the manufacture of veterinary medicinal products, an application must be submitted to the Ministry of Health.

Who can apply?

Wholesalers of veterinary medicinal products meeting the requirements set out by current legislation

What do I need?

• Application on plain paper
• proof of payment of the fee
• compliance with the requirements established, including the implementation of measures on good distribution practices for active substances used as starting materials for veterinary medicinal products in accordance with Regulation (EU) No. 2019/6 of the European Parliament and of the Council, provided for in Commission Implementing Regulation (EU) No. 2021/1280 of 2 August 2021.

Attachments to the application:

• a plan of the premises accompanied by a description of their conditions
• the certificate of registration in the professional register (pharmacist or chemist) of the technical director of the warehouse
• the declaration of acceptance of the assignment by the person in charge
• a declaration showing the types of pharmacologically active raw materials to be marketed
• proof of payment of the fee
• 1 16.00 EUR revenue stamp
• notification to the local competent authority and favorable opinion after inspection, if applicable.

Application form and guidelines

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How can I apply?

• Certified email (PEC)
  Certified email: dgsa@postacert.sanita.it
  Email subject: MDV-AIC-SFA
  

How long does it take?

• 60 days from the date of submission to the Ministry, where no inspection is needed
• 120 days from the date of submission to the Ministry, where an inspection is needed

How much does it cost?

Fee: € 325,27

Stamp duty: one : € 16,00 revenue stamp

Payment method

• Bank Transfer
  Institute: Banca d’Italia
  Current account heading: Ministero della salute - Direzione Generale della sanità animale e dei farmaci veterinari
  IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code (BIC) for payments made from abroad: BITAITRRENT
  Reason for payment: Registration - art. 95 of Regulation (EU) No. 2019/6
  

How do I know the outcome?

• Certified email

Outcome Publication

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Relevant law

Go to Trovanormesalute

Contact us

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Referent Office for Legal proceedings

Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari

Q&A

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Thematic site

• Recognition of health professions qualifications

Office

• Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)

Data ultimo aggiornamento: 31 marzo 2022