Requirements for operations
1. The persons referred to in Article 1(2) shall ensure that the identity of the veterinary medicinal product is not lost during wholesale distribution and shall use all means available to minimise the risk of falsified veterinary medicinal products entering the legal supply chain.
2. The persons referred to in Article 1(2) shall ensure that the wholesale distribution of veterinary medicinal products is performed according to the information on the outer packaging.
3. The persons referred to in Article 1(2) shall ensure that all veterinary medicinal products they distribute in the Union are:
(a)
covered by a marketing authorisation granted by a competent authority or the Commission, as applicable;
(b)
covered by a registration granted by a competent authority;
(c)
covered by an exemption, granted by a competent authority, from the requirements for marketing authorisation;
(d)
covered by an approval for parallel trade issued by the competent authority of the destination Member State;
(e)
covered by a permission to use in accordance with Articles 110(2) and (3) of Regulation (EU) 2019/6; or
(f)
in the case of products to be used under Articles 112(2), 113(2) or 114(4) of Regulation (EU) 2019/6, imported by holders of a manufacturing authorisation issued in accordance with Article 90 of that Regulation or in accordance with the procedures referred to in Article 106(3) of that Regulation, as applicable.
4. All key operations of the persons referred to in Article 1(2) shall be fully described in the quality system in appropriate documentation.
Verification of eligibility and approval of suppliers
1. Where veterinary medicinal products are obtained from a person referred to in Article 1(2), the receiving wholesale distributor shall verify that the supplier complies with good distribution practice for veterinary medicinal products as laid down in this Regulation and that they hold an authorisation. This information shall be obtained from the national competent authorities or the Union database on manufacturing, import and wholesale distribution referred to in Article 91(1) of Regulation (EU) 2019/6. Appropriate verification of eligibility and approval of suppliers shall be performed prior to any procurement of veterinary medicinal products. This process shall be controlled by a procedure and the results documented and periodically checked based on quality risk management principles.
2. When entering into a contract with new suppliers, the persons referred to in Article 1(2) shall carry out so called due diligence checks in order to assess the suitability, competence and reliability of the other party. The due diligence checks shall consider:
(a)
the reputation or reliability of the supplier;
(b)
offers of veterinary medicinal products more likely to be falsified;
(c)
large offers of veterinary medicinal products which are generally only available in limited quantities;
(d)
unusually high diversity of veterinary medicinal products handled by supplier;
(e)
abnormally low prices.
Verification of eligibility and approval of customers
1. The persons referred to in Article 1(2) shall perform initial and, as appropriate, periodic checks to establish whether their customers meet the requirements laid down in Article 101(2) of Regulation (EU) 2019/6. This may include requesting copies of a customer’s authorisations issued in accordance with national law, verifying status on a competent authority website and requesting evidence of qualifications or entitlement in accordance with national law.
2. The persons referred to in Article 1(2) shall monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of veterinary medicinal products shall be investigated and reported to competent authorities where necessary.
Receipt of veterinary medicinal products
1. The persons responsible for receiving veterinary medicinal products shall ensure that the arriving consignment is correct, that the veterinary medicinal products originate from approved suppliers and that they have not been damaged during transport.
2. Veterinary medicinal products requiring special storage or security measures shall be prioritised and, once appropriate checks have been conducted, those products shall immediately be transferred to appropriate storage facilities.
3. Batches of veterinary medicinal products intended for the Union market shall not be transferred to saleable stock before assurance has been obtained in accordance with procedures, that they are authorised for sale. For batches coming from another Member State, prior to their transfer to saleable stock, the control report referred to in Article 97(6) and (9) of Regulation (EU) 2019/6, the results of necessary tests, as applicable, referred to in Article 97(7) of that Regulation or another proof of release to the market in question based on an equivalent system, shall be carefully checked by appropriately trained personnel.
Storage
1. Veterinary medicinal products shall be stored separately from other products likely to alter them and shall be protected from the harmful effects of light, temperature, moisture and other external factors. Particular attention shall be paid to veterinary medicinal products requiring special storage conditions.
2. Incoming containers of veterinary medicinal products shall be cleaned, if necessary, before storage. Any activities performed on the incoming goods shall not impact on the quality of the veterinary medicinal products.
3. Warehousing operations shall be performed so as to ensure that appropriate storage conditions are maintained and allow for appropriate security of stocks.
4. Stock shall be rotated according to the ‘first expiry, first out’ principle. Exceptions shall be documented.
5. Veterinary medicinal products shall be handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups. Veterinary medicinal products shall not be stored directly on the floor unless the package is designed to allow for such storage, such as for some medicinal gas cylinders.
6. Veterinary medicinal products that are nearing their expiry date shall immediately be segregated from saleable stock physically or, if an equivalent electronic system is available, electronically.
7. Stock inventories shall be performed regularly taking into account the requirements of national law. Stock irregularities shall be investigated and documented.
Destruction of obsolete veterinary medicinal products
1. Veterinary medicinal products intended for destruction shall be appropriately identified, kept separately and handled in accordance with a procedure.
2. Destruction of veterinary medicinal products shall be carried out in accordance with the applicable requirements for handling, transport and disposal of such products.
3. Records of all destroyed veterinary medicinal products shall be retained for a period defined in the quality system referred to in Article 3.
Picking
Controls shall be in place to ensure that the correct veterinary medicinal product is picked. The veterinary medicinal product picked shall have an appropriate remaining shelf life and shall not have been damaged during storage.
Supply
1. An electronic or physical document shall accompany all supplies and include, in addition to the information referred to in Article 101(7) of Regulation (EU) 2019/6, a unique number to allow identification of the delivery order, the applicable transport and storage conditions and additional requirements specified by national law.
2. Electronic or physical records shall be kept so that the location of the veterinary medicinal product is known.
Export
1. When exporting veterinary medicinal products for which neither a national competent authority, nor the Commission, as applicable, has granted a marketing authorisation in accordance with Chapter III of Regulation (EU) 2019/6, wholesale distributors shall take appropriate measures to prevent those veterinary medicinal products reaching the Union market.
2. Where the persons referred to in Article 1(2) supply veterinary medicinal products to persons in third countries, they shall only supply those products to persons who are authorised or entitled to receive veterinary medicinal products for wholesale distribution or for supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
