OTC Medicinal Products Subject to Sales Restriction, State Institute for Drug Control

OTC Medicinal Products Subject to Sales Restriction

The State Institute for Drug Control (SÚKL) has been preparing the implementation of a new category of supply of medicinal products, “OTC medicinal products subject to sales restriction” on the grounds of provisions of Section 39 (3) of the new Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (“Act on Pharmaceuticals”).

Information for Marketing Authorisation Holders

OTC Medicinal Products Subject to Sales Restriction - Implementation of a New Category.

7. 08 2008

The “Positive List” of ATC groups

Below please find the “Positive List” , which contains ATC groups included in the new category as well as the proposed/relevant restrictions for supply.

7. 08 2008

The “Negative list” of ATC groups

For easier orientation, SÚKL has also created a “Negative list“ containing the ATC groups which pursuant to the Act on Pharmaceuticals cannot be classified as “OTC supply with sales restrictions” due to the nature of the active substance, the pharmaceutical form or indication (narcotic and psychotropic substances, products used parenterally, products with a risk of substance abuse, with serious adverse drug reactions or those necessitating further investigation).

7. 08 2008

State Institute for Drug Control