Human medicinal products which may be dispensed without medical prescription and which are not listed under Annex II to Commission delegated regulation (EU) 2016/161 (so called “black list”) must not bear safety elements (the UI or the ATD). Nevertheless, pursuant to Section 37, paragraph 8 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, the technical solution ensuring the medicinal product integrity employed by the marketing authorisation holder on the outer packaging of a medicinal product the dispensing of which does not require medical prescription and which has not been black-listed, shall not be considered a safety feature referred to under Commission delegated regulation (EU) 2016/161 (i.e. the safety feature regulation).
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