Supplementary Protection Certificates Waiver

​Supplementary Protection Certificates (SPC) waiver for manufacturing for export and for limited local storing of products covered locally by SPCs.

Regulation (EU) 2019/933 of 20 May 2019 amends Regulation (EC) No 469/2009 with a view to permit:

(i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or

(ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or

(iii) the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to  place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or

(iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.

A producer wishing to benefit from the above exemptions in respect of an SPC issued by the IP Registration Directorate of the Commerce Department in Malta needs to notify

a) IP Registration Directorate of the Commerce Department and

b) the SPC holder

no later than three (3) months before the start date of the production in Malta or no later than three (3) months before the first related act, prior to that production, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier;

The standard notification form may found here.

If the information listed in the notification changes, the producer must notify the Office and the certificate holder, before those changes take effect.

Notifications may be sent by e-mail to ipoffice@gov.mt

Alternatively they may also be sent by post to:

The Industrial Property Registrations Directorate

Commerce Department

Daħlet Gnien is-Sultan,

Lascaris Bastions,

Valletta VLT 1933

It should be noted that the Regulation requires that in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, a maker wishing to benefit from the waiver must ensure that a logo, in the form set out in Annex 1 of the Regulation, is affixed to the outer packaging of those  products, or the medicinal products containing those product, and, where feasible, to its immediate packaging.

The logo reproduced below shall appear in black and in such a size as to be sufficiently visible.