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  3. Authorization of veterinary medicinal products (VMP) through the independent national procedure (PIN)*

Authorization of veterinary medicinal products (VMP) through the independent national procedure (PIN)*

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Purpose of the procedure: The procedure (PIN) applies to valid national authorization requests for VMPs that have not received a marketing authorization (MA) in the EU and is limited only to the marketing of VMPs in Romania.


Setting up the PIN procedure:

  1. Submission of the letter of intent (at least 14 days before the start of the procedure)
  2. Submission of the technical documentation (TD) / Authorization request (see TD = part 1 - administrative information). The submission of the TD and its electronic structure is done in accordance with VET eSubmission, CESP (Common European Submission Portal)
  3. The national independent procedure (PIN) for VMP authorization lasts 210 days from the submission of a valid application.
  4. For all valid applications for which day 0 has been established, the TD evaluation of the VMP is carried out.
  5. Verification of the control methods used by the manufacturer and described in the quality specifications of the finished product (samples of the finished product presented in the packaging in which they are to be marketed, in the necessary quantities; samples are submitted by the applicant to the ICBMV headquarters or sent by courier), to ensure that they are appropriate, according to Art 463 (2) of Order 187/2007, with subsequent additions and amendments.
  6. In the case of non-compliant/incomplete requests, as applicable, ICBMV may request additional information to complete the TD; the previously specified period (210 days) is suspended ("stop clock" period) until the requested additional data is provided; the response time to ICBMV requests is 30 days from the date of notification;
  7. The maximum suspension period during the TD evaluation procedure is 6 months. If this period is exceeded, the authorization request is rejected and the applicant is notified regarding the return of the TD. The authorization procedure benefiting from the maximum suspension period of 6 months (182 days) is completed after 210 days + 182 days ("stop clock" period) = 392 days.
  8. Issuance of the marketing authorization (MA)
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Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Request for PMV authorization through the independent national procedure (PIN)*
Descarcă
Formular tipizat
The request will be found in Part I - Administrative Information of the technical documentation of the product. Types of requests: - Generic Products - according to Art. 13 para. (1) of Order 187/2007, respectively Art. 13 (1) of Directive 2001/82/EC; - Mixed application - according to Art. 13 para. (6) of Order 187/2007, respectively Art. 13(3) of Directive 2001/82/EC; - Similar biological product - according to Art. 13 para. (7) of Order 187/2007, respectively Art. 13(4) of Directive 2001/82/EC; - Well-established veterinary use - according to Art. 14 para. (1) of Order 187/2007, respectively Article 13a) of Directive 2001/82/EC; - Fixed combinations - according to Art. 15 of Order 187/2007, respectively Article 13b) of Directive 2001/82/EC; - Informed consent - according to Art. 16 of Order 187/2007, respectively Article 13c) of Directive 2001/82/EC; - Immunological Veterinary Medicinal Product for which the results of certain tests have not been submitted - according to Art. 17 of Order 187, respectively Article 13d) of Directive 2001/82/EC*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical documentation (DT)*
Descarcă
Scanned document
Technical documentation (DT = part 1 - administrative information; part 2 - quality documentation; part 3 - safety documentation; part 4 - efficacy documentation) in accordance with Art. 12 para. (5) of the Order of the President of ANSVSA no. 187/2007 with subsequent amendments and completions, respectively Directive 2001/82/EC and Eudralex - Notice to applicants, volume 6A*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Letter of intent*
Descarcă
Formular tipizat
Of course! Please provide the Romanian text or HTML code you'd like me to translate.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment*
Descarcă
Scanned document
It will be found in Part I - Administrative Information of the DT*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Marketing authorization*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
392
Calendar days
Case filling duration:
30
Calendar days
Notification deadline:
5
Calendar days
Appeal routes

According to Art. 46-13 from the Order of the ANSVSA president no. 187/2007 for the approval of the Veterinary Sanitary Norm regarding the Code of Veterinary Medicinal Products

(1) In case of an unfavorable opinion from the Commission for PMV authorization, the applicant is notified in writing by the ICBMV about the rejection of the authorization of the respective veterinary medicinal product.

(2) Within 30 days from the receipt of the rejection notification, the applicant may submit an appeal to ICBMV, which must be accompanied by detailed justifications supporting it.

(3) Within 30 days from receiving the appeal and the supporting documents, ICBMV requests the convening of the Commission for PMV authorization, in order to analyze and communicate the decision regarding the resolution of the appeal.

(4) The applicant may contest the response of the Commission for PMV authorization provided in paragraph (3).

(5) For resolving appeals, ICBMV may request scientific consultancy from the Committee for PMV, in accordance with the legal provisions in force.

(6) The decision regarding the rejection of PMV authorization may be contested according to the legal provisions in force.

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Additional information
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Last updated: 
28 March 2022
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institution responsible with document: 
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institute for the Control of Biological Products and Veterinary Medicines Icbmv*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
Institute for the Control of Biological Products and Veterinary Medicines Icbmv*
Str. Dudului 39
Telefon: 0212202112
Fax: 0212213171
Email: icbmv@icbmv.ro
www.icbmv.ro
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Evaluare PMV - Farmaceutice

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