A veterinary medicinal products wholesaler is a trader who has obtained a licence for opening (operating) a veterinary wholesale establishment or a licence for opening (operating) a medicinal products wholesale establishment with the special operating condition “distribution of veterinary medicinal products”.
Wholesale distribution comprises all activities involving the purchase, holding, supply or export of veterinary medicinal products, whether or not for profit, excluding the retail supply of veterinary medicinal products to the public.
To distribute veterinary medicinal products on a wholesale basis, a wholesaler must have:
- a special permit (licence) for opening (operating) a veterinary medicinal products wholesale establishment issued by the Food and Veterinary Service (FVS), and
- a Good Distribution Practice (GDP) certificate.
A special permit (licence) for opening (operating) a medicinal products wholesale establishment with the special operating condition “distribution of veterinary medicinal products”, as well as a Good Distribution Practice certificate issued by the State Agency of Medicines (SAM) until 31 December 2024, remain valid.
Medicinal products wholesalers that are already distributing veterinary medicinal products and wish to re-register their existing special permits (licences) for the distribution of veterinary medicinal products after 1 January 2025 must apply to the FVS to obtain a special permit (licence) for opening (operating) a veterinary medicinal products wholesale establishment, in accordance with Article 45.1 of the Pharmaceutical Law.
Medicinal products wholesalers that will start distributing veterinary medicinal products after 1 January 2025 must obtain a special permit (licence) for opening (operating) a veterinary medicinal products wholesale establishment and a Good Distribution Practice certificate issued by the FVS (in accordance with Article 45.1 of the Pharmaceutical Law).
To engage in the wholesale distribution of veterinary medicinal products, a veterinary medicinal products wholesaler must comply with the requirements for wholesale distribution and Good Distribution Practice (GDP) of veterinary medicines as laid down in:
- Chapter VII, Section 1 “Wholesale distribution” of 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;
- Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 on measures regarding good distribution practice of veterinary medicinal products in accordance with Regulation (EU) 2019/6.
A veterinary medicinal products wholesaler must also comply with the requirements set out in Latvian national legislation:
- Chapters III, VI and VIII of the Pharmaceutical Law: here
- Chapters 4 and 6 of Cabinet Regulation No. 35 of 11 January 2011 “Procedures for Issuing, Suspending, Re-registering and Cancelling Special Permits (Licences) for Veterinary Pharmaceutical Activities”: here
- Chapters 2, 7 and 10 of Cabinet Regulation No. 326 of 31 May 2016 “Regulations on the Distribution and Control of Veterinary Medicinal Products”: here
- Cabinet Regulation No. 327 of 31 May 2016 “Procedures for the Import and Export of Veterinary Medicinal Products”: here
Compliance with Good Distribution Practice (GDP) requirements must be assessed:
- Before starting operations, in order to obtain the special permit (licence) and the Good Distribution Practice certificate for opening (operating) a veterinary medicinal products wholesale establishment.
- If the veterinary medicinal products wholesaler already holds a special permit (licence) and has started operations, but the layout and/or arrangement of the premises at the same location/address changes.
- Before re-registration of the special permit (licence).
- Before obtaining the Good Distribution Practice certificate, based on a risk assessment.
NB! For information on re-registration, see the section “Re-registration of the special permit (licence)”.
The person in whose name the Good Distribution Practice (GDP) certificate and/or the special permit (licence) is to be issued shall submit to the central office or a territorial unit of the Food and Veterinary Service (hereinafter – FVS):
- an application for the assessment of the compliance of the veterinary medicinal products wholesaler – Annex 5 (here) of Cabinet Regulation No. 35 of 11 January 2011 “Procedures for Issuing, Suspending, Re-registering and Cancelling Special Permits (Licences) for Veterinary Pharmaceutical Activities” (hereinafter – Regulation No. 35).
The application must be accompanied by the documents specified in Paragraph 14 of Regulation No. 35, confirming compliance with the relevant requirements.
- In the event of a change in the premises or their layout (at the same location/address), documents relating to the premises must be attached.
Review of the application
The FVS shall carry out an initial review of the application and the documents attached thereto within five working days. If additional information is required during the review, it shall be requested in writing from the applicant.
After receiving the application and conducting its initial review, the FVS agrees with the applicant on the date of the compliance assessment inspection at the veterinary medicinal products distribution, storage, and quality control site specified in the application.
No later than 10 working days before the scheduled inspection, the FVS sends the applicant an official letter informing them of the date, time, and procedure of the inspection.
Depending on the size of the company and the specifics of its activities, the inspection may last 1 to 5 working days.
After the inspection:
- The FVS prepares a Good Distribution Practice inspection report, indicating and classifying deficiencies found during the inspection according to their severity. The report is sent to the applicant together with a cover letter specifying the deadline for submitting a corrective action plan.
- After evaluating the corrective action plan, the FVS informs the applicant of the need to submit an application for the special permit (licence).
- Based on the inspection report, the FVS makes a decision within 90 days after the inspection on whether to issue the Good Distribution Practice compliance certificate, to postpone issuance temporarily, or to refuse to issue the certificate.
- The FVS sends an invoice for the inspection in accordance with Cabinet Regulation No. 681 of 17 December 2019 “Regulations on the Procedure for Calculating and Making Payments for the State Supervision and Control Activities of the Food and Veterinary Service, and for Fee-Based Services”, Annex 4, Subparagraph 14.7. here
The special permit (licence) grants the right to distribute veterinary medicinal products on a wholesale basis.
The application for the special permit (licence) – Annex 7.1 of Regulation No. 35 (here) – must be submitted to the FVS after the compliance assessment with Good Distribution Practice (GDP) has been carried out.
The application for the special permit (licence) must be accompanied by a copy of the document confirming payment of the state fee.
The amount of the state fee for issuing a special permit (licence) is determined by Paragraph 2.1 of Cabinet Regulation No. 716 of 23 October 2007 “Regulations on the State Fee for Issuing a Special Permit (Licence) for Veterinary Pharmaceutical Activities” (here)
Based on the results of the compliance assessment, the FVS makes a decision regarding the special permit (licence) for opening (operating) a veterinary medicinal products wholesale establishment:
- Issuance of the permit (licence).
- Extension of the review period for the application if:
- additional information is required (information provided in the application or attached documents is insufficient or its authenticity is in doubt), or
- an additional inspection is necessary;
- a request has been submitted to supplement the application with new information or documents.
- Refusal to issue the special permit (licence) in cases specified in Paragraph 48 of Regulation No. 35.
Depending on the results of the compliance assessment, the FVS makes a decision:
- On compliance with Good Distribution Practice (GDP) requirements and on the issuance of the GDP compliance certificate, if it is found that the wholesaler meets the requirements of Regulation (EU) 2021/1248;
- On temporary postponement of the issuance of the GDP compliance certificate, specifying the reasons and the timeframe within which necessary corrective actions must be implemented, if deficiencies are identified that do not affect the quality of veterinary medicinal products and do not pose a risk to human or animal health or the environment, and if there is an agreement with the wholesaler on a plan to correct these deficiencies;
- On non-compliance with GDP requirements and refusal to issue the GDP compliance certificate, if it is found that the wholesaler does not meet the requirements of Regulation (EU) 2021/1248 or if the deficiencies that led to the decision to postpone issuance have not been corrected within the period set by the authority.
The GDP compliance certificate is issued together with the special permit (licence) for the operation of a veterinary medicinal products wholesale establishment after the GDP compliance assessment, based on the application for the special permit (licence) and the inspection report.
The special permit (licence) and the GDP compliance certificate are issued by the FVS for an indefinite period.
After the GDP compliance inspection, the FVS conducts a risk assessment of the wholesaler based on the specifics of its operations. Depending on the results of the risk assessment, the FVS conducts a re-inspection of the wholesaler’s compliance with veterinary medicinal products legislation at least once every five years, and a control report is prepared.
NB! The GDP compliance certificate and the special permit (licence) are not valid without the annexes specified in them.
Re-registration
Re-registration of the special permit (licence) is required when information stated in the special permit (licence) and/or its annex changes.
Re-registration is required in the following cases:
- The legal name and/or registered address of the licence holder changes;
- The wholesaler ceases activity in any of the specified types of operations;
- The wholesaler plans to engage in a new type of operation;
- The wholesaler changes the actual place of operations to another address;
- The responsible person for veterinary medicinal products distribution changes.
To re-register a licence, the following must be submitted:
- A free-form application requesting to supplement the special permit (licence) file with new information and documents, if the responsible person for veterinary medicinal products in the wholesaler is temporarily replaced for 30 to 120 days or the operating hours of the veterinary wholesaler change;
- An application for re-registration of the special permit (licence) in cases specified in Paragraph 31 of Regulation No. 35 – Annex 7.2;
- Documents specified in Paragraph 9 of Annex 5 of Regulation No. 35, only those relevant to the specific re-registration case.
The application and accompanying documents for re-registration must be submitted to the central office or a territorial unit of the Food and Veterinary Service (FVS).
A copy of the document confirming payment of the state fee must also be attached.
The amount of the state fee for re-registration of a special permit (licence) is determined in Paragraph 2.2 of Regulation No. 716: here
Review of the application
The FVS shall review the application for re-registration and its attached documents within five working days. If additional information is required during the review, it will be requested in writing from the applicant.
Assessment of compliance with Good Distribution Practice (GDP)
The FVS carries out a review of the submitted documents and/or an on-site inspection of the actual operations of the veterinary medicinal products wholesaler.
Before the assessment, the FVS agrees with the applicant on the date of the inspection.
FVS decision on re-registration of the special permit (licence)
Depending on the results of the application and/or the compliance assessment, the FVS makes a decision to:
- Re-register the special permit (licence);
- Extend the review period for the application if:
- Additional information is required (information in the application or attached documents is insufficient or its authenticity is in doubt);
- An additional inspection is necessary;
- A request has been submitted to supplement the application with new information or documents.
- Refuse to re-register the special permit (licence) in cases specified in Paragraph 48 of Regulation No. 35.
At least once every five years, the FVS conducts a re-inspection of the company’s compliance, based on a risk assessment, to ensure that the company adheres to the principles and guidelines of Good Distribution Practice (GDP) in its operations.
A fee is charged for the re-inspection, and an invoice is issued in accordance with Paragraph 14.7 of Annex 4 of Cabinet Regulation No. 681 of 17 December 2019 “Regulations on the Procedure for Calculating and Making Payments for the State Supervision and Control Activities of the Food and Veterinary Service, and for Fee-Based Services”: here
The FVS also has the authority to carry out unannounced inspections.
If violations of Good Distribution Practice (GDP) for veterinary medicinal products in wholesale distribution are identified that affect the quality of veterinary medicinal products and pose a risk to human or animal health or the environment, the FVS is entitled to make the following decisions:
- Refuse to issue the special permit (licence) if non-compliance with the requirements set out in the veterinary medicinal products legislation is found;
- Suspend the special permit (licence) until deficiencies are corrected, if any of the conditions specified in Paragraph 50 of Regulation No. 35 are met;
- Annul the special permit (licence) if any of the conditions specified in Paragraph 55 of Regulation No. 35 are met.
If non-compliance with Regulation (EU) 2021/1248 is identified, the FVS is entitled to decide:
- To temporarily postpone the issuance of the GDP compliance certificate;
- To refuse to issue the GDP compliance certificate due to non-compliance with GDP requirements.
(See also the section: “Good Distribution Practice (GDP) Compliance Certificate”)
- Important! The State Agency of Medicines (hereinafter – SAM) issued special permits (licences) for pharmaceutical activities, including special permits (licences) for pharmaceutical activities specifying veterinary medicinal products distribution as the special field of activity, until 31 December 2024. More detailed information is available on the SAM website.
- Information on all companies that have been issued a special permit (licence) for veterinary pharmaceutical activities by both the FVS and SAM is available in the FVS Register of Supervised Companies.
- Information on holders of special permits (licences) for veterinary pharmaceutical activities issued by the FVS is available on the FVS website.
- Information on issued, suspended, or annulled special permits (licences) and Good Distribution Practice (GDP) compliance certificates is also published in the EudraGMPD database.
For any questions or clarifications, please contact the Food and Veterinary Service (FVS) by email at pasts@pvd.gov.lv or by telephone at +371 67095267.