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Registration of the distribution of active substances used as starting materials in the manufacture of veterinary medicinal products


Italiano|English
Versione stampabile Printable version

La proceduraProcedure

Chi può richiederloWho can apply?

Cosa serve per richiederloWhat do I need?

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

Quanto tempo ci vuoleHow long does it take?

Quanto costaHow much does it cost?

Come viene comunicato l'esitoHow do I know the outcome?

Dove viene pubblicato l'esitoOutcome Publication

NormativaRelevant law

ContattiContact us

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

FAQQ&A

ProcedureProcedure

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?Who can apply?

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

What do I need?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 guidelinesApplication form and guidelines

Not present

How can I apply?How can I apply?

How long does it take?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?How much does it cost?

Rate: € 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
  • Through online payment via the integrated Online Payment connected with PagoPA

How do I know the outcome?How do I know the outcome?

  • Certified email

Outcome PublicationOutcome Publication

not present


Relevant lawRelevant law

  • Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC


Consulta il Trovanormesalute

Contact usContact us

not present


Referent Office for Legal proceedingsReferent Office for Legal proceedings

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

FAQFAQ

Not present

Thematic SiteThematic Site

OfficeOffice


Last modified date: 31 March 2022


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