AstraZeneca A/S v Lægemiddelstyrelsen.
Date: 2003-10-16
23.  To that end, the applicant must show that
─  the medicinal product for which the marketing authorisation is sought is essentially similar to another medicinal product, namely the reference medicinal product;
─  the reference medicinal product has been authorised within the Community, in accordance with the Community provisions in force, for at least six or ten years;
─  the reference medicinal product is   "marketed in the Member State for which the application is made"  .
27.  In order to be able to grant a marketing authorisation for a generic medicinal product on the basis of the abridged procedure laid down in the provision at issue, what matters is that all the particulars and documents relating to the reference medicinal product remain available to the competent authority for the Member State where the application for the marketing authorisation is made and not that the reference medicinal product has in fact been placed on the market.
42.  Second, it should be recalled that the abridged procedure established by the provision at issue, which, in certain circumstances, exempts the manufacturers of medicinal products which are essentially similar to already authorised medicinal products from having to provide the results of pharmacological and toxicological tests or of clinical trials, was introduced to enable those manufacturers to save the time and expense needed to gather that data and, in accordance with the fourth recital in the preamble to Directive 87/21, to avoid the repetition of tests on humans or animals where not absolutely necessary (see, to that effect, Case C-368/96   Generics (UK) and Others   [1998] ECR I-7967, paragraph 4).
43.  However, in laying down the conditions which must be met in order to have recourse to the abridged procedure, the Community legislature also took account of the interests of innovating firms, as is clear from the second recital of Directive 87/21, in particular by making that procedure subject to the condition that the reference medicinal product has been authorised within the Community for six or ten years (see   Generics (UK) and Others  , cited above, paragraphs 72 and 73).
44.  Lastly, it is important to bear in mind that Directive 65/65 must be interpreted and applied by reference to its primary purpose, which, as is stated in the first recital to that directive, is to safeguard public health (see, to that effect,   Generics (UK) and Others  , paragraph 22, and Case C-15/01   Paranova Läkemedel and Others   [2003] ECR I-4175, paragraph 24).
53.  It does not compromise the objective of safeguarding public health pursued by Directive 65/65. In that regard, it should be remembered that application of the abridged procedure may not result in a relaxation of the requirements of safety and efficacy which must be met by medicinal products (see   Generics (UK) and Others  , paragraph 22). Therefore, if the health authorities of the Member State concerned consider, in specific cases and for clearly identified reasons, that the lack of a pharmacovigilance obligation on the holder of the withdrawn marketing authorisation could compromise the safeguarding of public health, they must be able to adopt the appropriate measures, namely, where necessary, they must be able to refuse to use the abridged procedure for granting marketing authorisation of a generic medicinal product.