Introduction
The guideline provides detailed definitions of terms and stipulates conditions governing the submission of information and source documents to the State Institute for Drug Control (SÚKL) in the area of development and distribution of educational materials targeting healthcare professionals and patients. The Guideline is being issued on the basis of and in compliance with the provision of Section 91, paragraph 4 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, and Guideline on Good Pharmacovigilance Practices (GVP), Module I, V (rev. 2), X, XV, XVI, Addendum to Module XVI. The Guideline is legally binding.
Related regulations:
Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended
Act No. 95/2004 Coll., Concerning the Conditions for Receiving and Recognition of Basic Qualification and Specialist Qualification for Performing the Medical Profession of Physician, Dentist and Pharmacist
Decree No 228/2007 Coll., on Marketing Authorisation of Medicinal Products
Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts
Act No 40/1995 Coll., on Advertising Regulation
Decree No. 228/2008 Coll., on Marketing Authorisation of Medicinal Products, as amended
Guideline on good pharmacovigilance practices (GVP), Module I, V, X, XV, XVI, Addendum to Module XVI.
Directive No 198/2013 of the European Parliament and of the Council
Abbreviations:
| CAP | Centrally authorised product |
| CHMP | Committee for Medicinal Products for Human Use |
| CMDh | Coordination Group for Mutual Recognition and Decentralised Procedures |
| DC | Decentralised procedure |
| EM | Educational materials |
| EMA | European Medicines Agency |
| EU | European Union |
| GVP | Guideline on good pharmacovigilance practices |
| MA | Marketing Authorisation |
| MP | Medicinal product |
| MRP | Mutual recognition procedure |
| PIL | Patient Information Leaflet |
| PRAC | Pharmacovigilance Risk Assessment Committee |
| RMP | Risk management plan |
| SmPC | Summary of Product Characteristics |
| SÚKL | State Institute for Drug Control |