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) 2019/6 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.