Documentation requirements
1. Documentation shall fulfil the following requirements:
(a)
be readily available or retrievable;
(b)
be sufficiently comprehensive with respect to the scope of the activities of the persons referred to in Article 1(2);
(c)
be written in a language understood by personnel;
(d)
be written in clear, unambiguous language.
2. Documentation shall be approved, signed and dated by appropriate authorised persons, as required. It shall not be handwritten, unless handwritten records are justified for practical reasons. In that case, sufficient space shall be provided to make those records.
3. When errors in the documentation are identified, they shall be corrected without delay, with clear traceability of who corrected them and when.
4. Any alteration made in the documentation shall be signed and dated. The alteration shall permit the reading of the original information. Where appropriate, the reason for the alteration shall be recorded.
5. Documents shall be retained for at least 5 years or for the period stated in the applicable national law, if that period is longer than 5 years. Personal data shall be deleted as soon as their storage is no longer necessary for the purpose of distribution activities.
6. Each employee shall have ready access to all necessary documentation for the tasks executed.
7. Relationships and control measures for original documents and official copies, data handling and records shall be stated for all paper-based, electronic and hybrid systems.
Procedures
1. Procedures shall describe the wholesale distribution activities affecting the quality of veterinary medicinal products. Those activities include:
(a)
receipt and checking of deliveries; suppliers and customers control;
(b)
storage;
(c)
cleaning and maintenance of the premises and equipment, including pest control;
(d)
checking and recording of storage conditions;
(e)
protection of veterinary medicinal products during transport;
(f)
security of stocks on site and of consignments in transit;
(g)
withdrawal from saleable stock;
(h)
handling of returned veterinary medicinal products;
(i)
recall plans;
(j)
qualification and validation;
(k)
procedures and measures for the disposal of unusable veterinary medicinal products;
(l)
procedures for investigating and resolving complaints;
(m)
procedures for identifying veterinary medicinal products suspected of falsification.
2. Procedures shall be approved, signed and dated by the responsible persons.
3. Valid and approved procedures shall be used. Documents shall be clear and appropriately detailed. The title, nature and purpose of documents shall be stated. Documents shall be reviewed regularly and kept up to date. Version control shall be applied to procedures. After revision of a document, a system shall exist to prevent inadvertent use of the superseded version. Superseded or obsolete procedures shall be removed from workstations and archived.
Records
1. Records shall be kept either in the form of purchase or sales invoices, delivery slips, or in electronic form, for any transaction in veterinary medicinal products received or supplied.
2. In addition to the detailed records referred to in Article 101(7) of Regulation (EU) 2019/6, records shall include any additional requirements specified by national law, as appropriate.
3. Records shall be made at the time each operation is performed. If handwritten, they shall be made in clear, legible and indelible handwriting.
