The sunset clause is linked to the marketing authorisation and hence to the MA number associated with this particular marketing authorisation. The period of the 3 years during which the marketing authorisation holder is obliged to place the medicinal product onto the market is calculated from the coming legally into force of the marketing authorisation of the medicinal product, not from the date of code-adjustment. For products whose marketing authorisation came legally into force prior to December 31 2007 please see Question 7 above.
Example:
The medicinal product has been authorised in 5mg, 10mg and 20mg strengths under marketing authorisation number 01/111/11-C. Thereafter, code-adjustment to the following MA numbers has been performed:
- 5mg – 01/111/11-A/C
- 10mg – 01/111/11-B/C
- 20mg – 01/111/11-C/C
In order to safeguard the presence of the medicinal product on the market, it shall suffice to have 10,000 DDDs for MA number 01/111/11-C, i.e. the sum total of consumption of all strengths of this product.
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