11 (1) Subject to subsection 13(2), if the total of the fees payable under sections 3 to 10 of these Regulations and the fee payable under section 3 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations is greater than an amount equal to 1.5% of the applicant’s actual gross revenue from the sale, testing and packaging/labelling of drugs, as well as controlled drugs and narcotics not in dosage form, for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides, with their application for the annual review of their licence, a statement signed by ...[+++] the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

Nor do they cover the licensing of software copyright and distribution of software by means of ‘shrink wrap’ licences, that is, a set of conditions included in the package of the hard copy which the end user is deemed to have accepted by opening the wrapping of the package, or the licensing of software copyright and distribution of software by means of online downloading.

In the unopened, original container (sealed under nitrogen) and in a cool place it can be stored for about 12 months.

3. Marking shall be carried out in accordance with Annex III, under official surveillance and after sealing, on the unit of packaging in which the product is to be marketed.

6.2. Each axle set shall be contained in a sealed package constructed to show previous opening.

'However, where products of animal origin arrive in containers or are wrapped or packaged under vacuum, the identity check may be limited to ensuring that the seals placed by the official veterinarian or the competent authority on the container or package are intact and that the indications given thereon correspond to those included in the accompanying document or certificate'.