S.L. 437.115 · Veterinary Medicinal Products (S.L. 437.115)
S.L. 437.115 Art. 30Veterinary prescription.
(1) This regulation shall apply to veterinary medicinal products which require a veterinary prescription as per Article 34 of Regulation (EU) 2019/6 and to products or substances that may not be classified as veterinary medicinal products, but which may be deemed by the Director to require a veterinary prescription for their administration to animals:
Provided that this regulation shall not apply to veterinary prescriptions issued for the preparation, placing on the market and use of medicated feed.
(2) No person shall alter a veterinary prescription unless authorized to do so by the veterinary surgeon who has issued the prescription:
Provided that the veterinary surgeon who authorised that the veterinary prescription be altered and the dispenser shall keep a note to this effect.
(3) Veterinary prescriptions shall be printed or handwritten in indelible ink, signed in original handwriting and rubber stamped by the veterinary surgeon who issues the veterinary prescription:
Provided that in the event that the veterinary prescription is printed, the signature and rubber stamp of the veterinary surgeon shall be made in ink which is different from the printing ink:
Provided further that this regulation shall not be applicable to electronic veterinary prescription.
(4) In addition to the elements listed in Article 105(5) of Regulation (EU) 2019/6, a veterinary prescription issued in the territory of Malta shall also include the following:
(a) the name of veterinary medicinal products or medicinal products for human use dispensed, including their active substances and pharmaceutical form and strength;
(b) the quantity dispensed or the number of packs, including pack size;
(c) the disease treated or prevented;
(d) the name, signature and stamp of the dispenser of the veterinary medicinal products or medicinal products for human use, including the professional number, if available;
(e) the name and address of premises from where the veterinary medicinal products or medicinal products for human use are dispensed; and
(f) the dates when the veterinary medicinal products or medicinal products for human use were dispensed.
(5) The dispenser shall not accept verbal instructions unless all the following conditions are satisfied:
(a) that the dispenser is satisfied that the verbal instruction comes from a veterinary surgeon who by reason of an emergency is unable to furnish a veterinary prescription;
(b) that the veterinary surgeon undertakes to furnish the dispenser with a veterinary prescription within forty-eight
(48) hours of the verbal instruction; and
(c) that the product is dispensed in accordance with the directions of the veterinary surgeon.
(6) If not all the products on the veterinary prescription are dispensed, the dispenser shall make a note on the veterinary prescription to that effect.
(7) In case more than one (1) product is listed on the veterinary prescription and not all of them are dispensed from a single
(1) place from where veterinary medicinal products can be retailed in accordance with the regulation 18, the dispenser shall make a note on the veterinary prescription to that effect. The dispenser shall note on the veterinary prescription which product and how many of the products were dispensed. The dispenser shall keep an accurate account of the course of action he has taken. The veterinary prescription may then be given to another dispenser by the customer, whereupon if the rest of the products are dispensed, it shall be considered as supplied in its entirety:
Provided that this regulation shall apply also to products which are only partially dispensed from a single (1) place with the remaining quantities of the same product dispensed from another place.
(8) A veterinary prescription for veterinary medicinal products that are not antimicrobials or that do not contain narcotic or psychotropic drugs shall be valid for a period not exceeding six (6) months from the date of issue.
(9) A veterinary prescription for veterinary medicinal products containing narcotic or psychotropic drugs shall be valid for a period not exceeding one (1) month from the date of issue.
(10) Pursuant to Article 105(12) of Regulation (EU) 2019/6, a veterinary medicinal product or a medicinal product for human use classified as subject to a veterinary prescription may be administered personally by the veterinary surgeon without a veterinary prescription, provided that they do not contain antimicrobials or narcotic or psychotropic drugs.
(11) The veterinary surgeon, dispenser and the animal owner or keeper shall keep the veterinary prescriptions for a period of not less than five (5) years and shall be made readily available to the Director upon his request.
Verweist auf
- S.L. 437.115 Art. 105
- S.L. 437.115 Art. 34