Principles for compiling the list of mutually substitutable medicinal products with marketing authorisation at the Finnish Medicines Agency.
Under the Medicines Act and the Sickness Insurance Act as amended in 2002, it is the duty of the National Agency for Medicines to compile a list of mutually substitutable medicinal products that contain the same quantity of the same active agent and are biologically equivalent. The reform of the Medicines Act in November 2005 has brought changes to the definition of active agent, in that different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of the active agent can now be considered to be the same active agent unless there are significant differences between them in terms of their safety, efficacy or both. This means that different salts of the same active agent become mutually substitutable, provided they otherwise meet the criteria for substitutability.
The list will include products for which a marketing authorisation has been granted and that meet the criteria, whether they be original products or parallel products (generic products). Parallel import or parallel distribution products are in general substitutable irrespective of pharmaceutical form or ATC group (Anatomical Therapeutic Chemical classification). Not all products carrying a marketing authorisation nor all their pack sizes are actually on the market.
The following basic criteria are applied for products to be included in the list of substitutable medicinal products: the products 1) contain the same active agent, 2) contain the same quantity of the active agent, 3) have the same pharmaceutical form, although tablets may be substituted for capsules or capsules for tablets, 4) have been reliably shown to be biologically equivalent, and 5) enouhg broad therapeutic index and safety profile.
Pharmaceutical dosage forms which are substitutable
Differences in pack size or type, in package opening or appearance or in tablet size, shape or colour do not influence substitutability. Physicians may forbid substitution on medicinal or therapeutic grounds if they consider that certain product properties (rheumatics-friendly closure, capsule size, administration etc) will affect either the usability of the medicinal product or patient compliance.
The list of substitutable products will not include products
- nicotin products
- belonging to ATC groups where substitution by parallel products is not appropriate for pharmacological or clinical reasons (substitution by a parallel import or parallel distribution product is possible); these include warfarin, cardiac glycosides, most antiarrhythmics, antiserums, vaccines and antiepileptics.
The summaries of product characteristics and package leaflets for substitutable products may differ somewhat from each other. This is explained by the fact that some of the products have been granted marketing authorisations through EU marketing authorisation procedures. For parallel products, the EU-wide summary of product characteristics often has somewhat more restricted indications and more contraindications and warnings than for older products. This rarely causes problems in actual treatment situations and can be handled when writing the prescription.
The list is updated quarterly and published on the Fimeas website.