Draft Law on Amending the Law on Pharmacy Presented to the Seimas for Consideration
On 9 October 2007, the Seimas of the Republic of Lithuania was presented with Draft Law No. XP-2575 on Amending and Supplementing Articles 8, 23 and 57 of the Law on Pharmacy (hereinafter referred to as the Draft).
The Draft proposes to supplement the Law of the Republic of Lithuania on Pharmacy (official gazette Valstybės Žinios, 2006, No. 78-3056) (hereinafter referred to as the Law on Pharmacy) with a provision that it is prohibited to market, distribute, sell (dispense) to the final consumer any pharmaceutical preparations with the expired term of validity. The Law on Pharmacy, as currently in effect, does not provide for a direct prohibition to market pharmaceutical preparations with the expired term of validity. Upon adoption of this provision, there would be more legal certainty in case of evaluation of acts of business entities when the fact of sale of a pharmaceutical preparation with the expired term of validity is established.
The Draft also proposes to amend paragraph 1 of Article 23 of the Law on Pharmacy establishing that the validity of a licence can be suspended only in case of breach of conditions of the licensed activity and/or duties of the licence holder, when such a breach can be dangerous to human health or can have a negative impact on the quality of pharmaceutical preparations. This wording is milder, whereas the sanction provided for in the Law on Pharmacy, as currently in effect to suspend the validity of a licence in all cases of indicated breaches can often be too strict.