1. Veterinary prescriptions
The European Regulation on veterinary medicinal products (ER 2019/6) came into effect on 28 January 2022. Since then, some additional information must be included on the veterinary prescriptions. This information was to be added by the veterinarian to existing model formats.
The Ministerial Decree of 27 August 2024 establishing the model of the Administration and Supply Document and the model format for veterinary prescription was published in the Belgian Official Gazette on 3 September 2024.
As from 13 September 2024, veterinarians will have to use the new model format for veterinary prescription.
From now on, there is only one model format valid for all animals.
However, the old model formats can still be used until 13 March 2025, provided they include all the elements required by law.
A specific communication outlining the various phases involved in implementing the new model format was issued in September 2022 .
Phase 2 shall start 13 September 2024 and end 13 March 2025.
Phase 3, for which only the new model format shall be valid, shall start 14 March 2025.
A veterinary prescription shall contain at least the following elements:
- identification of the animal or groups of animals to be treated;
- full name and contact details of the animal owner or keeper;
- Date on which the prescription was issued;
- full name and contact details of the veterinarian including, if available, the professional number;
- signature of the veterinarian;
- name of the prescribed medicinal product, including its active substances;
- pharmaceutical form and strength;
- quantity prescribed, or the number of packs, including pack size;
- dosage regimen;
- for food-producing animal species, withdrawal period even if such period is zero;
- any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials;
- if a medicinal product is prescribed under the "cascade" system, a statement to that effect;
- if an antimicrobial medicinal product is prescribed for metaphylactic or prophylactic use, a statement to that effect.
The Ministerial Decree of 27 August 2024 laying down the model administration and supply document and the model veterinary prescription was published in the Belgian Official Gazette on 3 September 2024 and entered into force on 13 September 2024.
From 13 September 2024, a six-month transition period started, during which the old model veterinary prescriptions could still be used provided they included all the legally required elements. This transition period ended on 13 March 2025.
According to the specific communication issued in September 2022 and describing the various phases in the introduction of the new model prescription, phase 2 is the transition period that started on 13 September 2024 and ended on 13 March 2025.
During this transition period, three models co-existed:
• the new Belgian model,
• the old two-part Belgian model completed as requested in phase 1, and
• the old three-part Belgian model completed as requested in phase 1.
Phase 3 started on 14 March 2025, at the end of the transition period. Since, the only the new model prescription is valid.
Due to a delay in the supply of prescriptions to veterinarians, the FAMHP noted after 14 March 2025 that not all veterinarians yet had the model prescriptions conforming to the model set out in the Ministerial Decree of 27 August 2024.
In order to ensure the continuity of animal care, and pending a Ministerial Decree extending the six-month transition period for the old model veterinary prescriptions, the FAMHP has published a circular to the attention of its inspection services, asking them to no longer give priority to checking the conformity of the model veterinary prescriptions.
2. Administration and Supply Documents
Ever since the European Regulation on veterinary medicinal products (ER 2019/6) came into effect on 28 January 2022 as well as the Royal Decree of 29 May 2024 amending the Royal Decree of 21 July 2016, the information on the Administration and Supply Document (ASD) has to be modified. Until now, the missing information had to be added either manually by the veterinarian to the existing ASD model, or on the digital form sent by the veterinarian.
The Ministerial Decree of 27 August 2024 establishing the model of the Administration and Supply Document and the model format for veterinary prescription was published in the Belgian Official Gazette on 3 September 2024.
As from 13 September 2024, veterinarians who wish to fill in an ASD by hand, must use the new ASD model included in Annex 1 of the Ministerial Decree of 27 August 2024.
However, the previous ASD models can still be used until 13 March 2025, provided they include all the elements required by law.
A specific communication outlining the various phases involved in implementing the new ASD model was issued in September 2022.
Phase 2 shall start 13 September 2024 and end 13 March 2025.
Phase 3, for which only the new ASD model shall be valid, shall start 14 March 2025.
This ASD model is only required for handwritten documents. It is not required for digital documents.
Handwritten ASDs (paper version) can either be printed from the model annexed to the Ministerial Decree, or purchased from certified organisations committed to fighting animal diseases (ARSIA and DGZ). In all cases, a copy shall be sent to the person responsible for the animals, and another to the veterinarian.
The minimum elements required by law to be included on ASDs are:
- first and last name of the veterinarian who supplied or administered the medicinal product, and his or her registration number with the Order of Veterinarians;
- date on which the medicinal product is administered or supplied;
- exact name of the medicinal product;
- quantity administered or supplied;
- first and last name of the veterinarian in charge of the depot where the medicinal product comes from, as well as the identification number and administrative address of the depot;
- identification of the animal or group of animals to be treated;
- category of animals to be treated;
- Indications for use of the medicinal product supplied, including dosage and duration of treatment. If the animal for which the medicinal product is supplied, is included in the target species of the package leaflet and the indications are consistent with those given on the package leaflet, the indications may then be replaced by the words "see package leaflet";
- withdrawal period to be observed if different from package leaflet;
- disorder to be treated when medicinal products are supplied under a veterinary guidance agreement;
- batch number;
- marketing authorisation number;
- name and address of the person responsible and, if available, address of the herd where the animals are kept.
Each ASD must be uniquely numbered.
Where relevant, the "paper" ASD can be used to keep record of the medicinal products leaving the veterinarian's depot (information in compliance with Article 103 of ER 2019/6) and as record-keeping by the person responsible for the animals (information in compliance with Article 108 of ER 2019/6).
3. Record-keeping by the person responsible for the food-producing animals
The records of the person responsible must comply with Article 108 of ER 2019/6 and contain at least the following information:
- date of the first administration of the medicinal product to the animals;
- name of the medicinal product;
- quantity of the medicinal product administered;
- name or company name and permanent address or registered place of business of the supplier;
- evidence of acquisition of the medicinal products they use;
- identification of the animal or group of animals treated;
- name and contact details of the prescribing veterinarian, if applicable;
- withdrawal period even if such period is zero;
- duration of treatment.
The ASD is evidence of the medicinal products acquired.
The records are kept per animal species and consist of three parts: the records of the medicinal products entering and leaving the depot, and lab results justifying the use of critical antibiotics where relevant.
The records can be kept in digital format.
The entry records are kept by the person responsible as he collects and chronologically classifies the ASDs, and prescriptions dispensed by the pharmacist.
If the medicinal product is administered by the person responsible no later than the day following the date on which it was supplied, the ASD also serves to keep record of the medicinal products leaving the depot.
If the administration occurs later, the person responsible must either legibly enter the date of the first administration on the ASD ("paper" version), or enter it in separate exit records.
The administration of medicinal products supplied as part of the guidance process and administered by the person responsible or under his responsibility is registered in the exit records.
Each time an administered medicinal product is registered in the exit records, the person responsible writes down the corresponding ASD number.
More information
European regulation on veterinary medicinal products (EU) 2019/6