3. How shall be the period of 3 years calculated pursuant to Section 34a (1) and (2) of the Act on Pharmaceuticals?

The provision in Section 34a of the Act on Pharmaceuticals differentiates between two periods of 3 years which are linked to expiration of marketing authorisation.

The first period of 3 years pursuant to Section 34a (1) of the Act on Pharmaceuticals shall commence on 1st January of the following year after the marketing authorisation has become binding – the marketing authorisation holder shall launch the medicinal product, i.e. introduce it to the distribution chain, pursuant to Section 3a (10) of the Act on Pharmaceuticals in the course of these three years.

The other period of 3 years pursuant to Section 34a (2) of the Act on Pharmaceuticals shall commence on 1st January of the following year after the date of market launch of the medicinal product – at least one pack must be in the market in the course of 3 consecutive years from this date.