Personal Use Waiver

Personal Use Waiver

In certain situations it is possible for people to get veterinary medicinal products from sources other than those approved by the Veterinary Medicines Unit.

In accordance with Regulation 4D of S.L as amended by LN 179 of 2021 the legal conditions that may allow such an exemption are as follows:  

(a) the products shall not be re-sold for monetary gain;

(b) the products shall not be transferred to other third parties unless such transfer is authorised by the Veterinary Medicines Unit;

(c) this provision is not applicable to psychotropic drugs, narcotic drugs for all animals and in the case of food producing animals also the substances listed in Group A in Schedule I of Measures to monitor certain Substances and Residues thereof in Live Animals and Animal Products Rules and Table II of Regulation (EU) 37/ 2010;

(d) the quantity of products obtained shall be proportional to the dosage regime of the condition it will be used for;

(e) the quantity of products which is allowed entry in Maltese territory shall cover the period indicated as the duration of treatment in the product’s specifications or on the veterinary surgeons ‘s veterinary prescription. However, products intended to be used for recurrent or chronic conditions can be allowed entry in Malta several times a year, provided that cogent evidence that demonstrate the benefits obtained by the regular use of the products can be provided;

(f) the individuals shall be required to provide a veterinary prescription for products classified as requiring such a prescription in the country from where they are obtained or for similar veterinary medicinal products in Malta:

Provided that the Veterinary Medicines Unit may still ask for such a veterinary prescription even if the products are classified as not requiring a veterinary prescription in the country from where they are obtained;

(g) only products that do not contain animal by-products which are derived from high risk areas where certain diseases may be, or suspected to be, present or prevalent, can be obtained;

(h) only products that do not contain ingredients that are classified as illegal in Malta and do not have banned indications in Malta can be obtained;

(i) only appropriately labelled products which give clear indication of the nature of the ingredient/s within can be obtained;

(j) food producing animals administered with the veterinary medicinal products authorised in accordance with this regulation can only be consumed by the person getting the veterinary medicinal products, or by consenting members of the same household. The appropriate withdrawal period shall apply;

(k) before a decision on antimicrobial veterinary medicinal products and products that have a hormonal activity is taken, a risk assessment shall be prepared by the Veterinary Medicines Unit in a timely manner;

(l) the decision by the Veterinary Medicines Unit is without prejudice to any license or permit that the person getting the veterinary medicinal products may need to obtain under other regulations of the same or of different department. ​

(m) the Veterinary Service does not have remit to decide on the procurement of medicinal products for human use that will be used on animals;

(n) procurement of immunological products in this way is discouraged, especially for live or attenuated immunological products. Proof of the presence of the particular microbe or strain must be provided for the latter. Immunological products usually have very specific and controlled transport conditions.

Points on the vetting of postal parcels by the Veterinary Medicines Unit


·      The most common way such products are intercepted by the Veterinary Medicines Unit is through postal parcels that are sent by Malta Post for the vetting of the Veterinary Medicines Unit.

·        The Veterinary Medicines Unit vets the content of the parcels according to the criteria above  and its professional competence. It may then give its no objection for the release of the products from customs.

·    For a quick evaluation, an invoice with all the details of the supplier and consignee should be enclosed in the posted parcel. Details about the nature of the product is essential.  

·   Due to a high risk factor antimicrobial agents, narcotics, physcotropics and certain high risk hormones  should not be obtained in this way. The Veterinary Medicines Unit does not normally give its no objection for release of such products.  

·        Whoever intends to bring veterinary medicinal products this way is advised to consult Subsidiary Legislation 117.14 before importing veterinary products.

·    Whoever intends to bring veterinary medicinal products in this way should keep in mind that imprudent use of veterinary medicinal products, e.g. antimicrobials, can have severe consequences, e.g. Antimicrobial Resistance. This is considered very carefully by the Veterinary Medicines Unit when making its vetting. 

·        Preferably veterinary medicinal products not available in Malta are brough through Articles 110, 112-114 of Regulation (EU) 2​019/6 i.e. the cascade articles. It is best if the personal use waiver is used as a last resort or when the condition to be treated is minor or a known chronic one.   [ss2]