The meetings were attended by:
Mr Igor Novák, MPH
Mgr. Patrik Bilanin, Secretary of the Slovak Republic
Ing. Silvia Sur, Secretary General ZCHFP SR
MUDr. Branislav Budke, President of the AIFP, Chairman of the PK Farming at ZCHFP SR, member of AZZZ Presidium
PharmDr. Michael Palágyi, PhD., GENAS
Dr Teresa Szádocká, GENAS
PharmDr. Koloman Gachall, President of the ADL
Dr. Julius Fíger
Mr Roman Guba, SOOL
For MZ SR:
State Secretary, MUDr. Jaroslav Ridoško, PhD. MBA
Director General of the Department of Pharmacy and Drug Policy MUDr. Peter Musil, MSc.
Director of the Department of Classification and Pricing: PharmDr. Miriam Vulevová, MBA
Categorisation and pricing officer: Mgr. Judita Janeková
The meeting was opened by Mr. State Secretary, Mr. Jaroslav Ridoško, PhD. MBA.
Meeting topics:
- Merciful Treatment
- re-export of medicines, availability of medicines
- radiopharmaceuticals in clinical trial
- FMD
- Merciful Treatment
MUDr. Budke said that the issue of merciful treatment and its non-taxation with withholding tax had already been resolved in the past and agreed with the Ministry of Finance of the Slovak Republic, the drug law itself was not reflected despite the comment. MZ SR accepted the proposal of the AIFM not to tax merciful treatment. The AIFM shall send the prepared legislative proposal to the Director of OKC PharmDr. Vuleva by Wednesday 22.8.2018. Subsequently MZ SR should take care of the legislation.
- Reexport of medicinal products
The control activity of ŠÚK and MZ SR did not show an increase in re-export. The situation in the availability of categorised medicinal products has normalized on the SR market. MZ SR is suspected of misuse of the application for withdrawal of a medicinal product from the categorisation (A3) because the holder of the registration of the categorised medicinal product is not at risk of imposing a penalty for the non-availability of the medicinal product. The lack of some medicines may also be due to the commercial policy of pharmaceutical companies, which, due to the low European reference price of the medicine in Slovakia, restrict the supply of some medicines to the Slovak Republic. MZ SR also adopted measures against pharmacies in the last amendment of the Act 362/2011 Coll., aimed at restricting the sale of medicines among pharmacies. Similarly, the number of holders of a repacking authorisation has increased. The holder of this authorisation may export medicinal products.
- radiopharmaceuticals in clinical trial – radiation protection obligations
Amendment to Act 362/2011 The Z. z. does not directly modify the requirements for radiopharmaceuticals if they are subject to a clinical trial. It refers to the new Act No.87/2018 Coll. on radiation protection and on the amendment of certain laws. This law takes over all EU radiation protection requirements. Regulation 2014/536 on clinical trials imposed on EU Member States to respect all EU legislation on radiation protection. The Association of Chemical and Pharmaceutical Industry of the Slovak Republic did not comment on this issue in the MPK and are not listed in the annex to letter 25/2018.
Similarly, the issue of genetically modified organisms (Law No 151/2002 Coll. on the Use of Genetic Technologies and Genetically Modified Organisms) and the issue of human cells, human tissues and human organs (Law No 317/2016 Coll. on requirements and procedures for the procurement and transplantation of human organs, human tissues and human cells and on amendments to certain laws (Transplantation Act). MZ SR will address this problem from a legislative point of view.
MUDr. Novák explained that this was a legislative and technical problem. The amendment of Act No. 87/2018 Coll. on radiation protection and on the amendment of certain laws created additional obligations that increase unnecessary administration. Representatives of the Slovak Republic accepted the comments of the AIFM and agreed to send them a legislative proposal to eliminate the problem by Wednesday 22.8.2018.
- FMD Directive 2011/62/EU adopted by the European Parliament and the Council
Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry of falsified medicinal products into the legal supply chain, was fully transposed into Act No 362/2011 Coll. on medicinal products and medical devices by Amendment No 459/2012 Coll. Directive 2011/62/EU authorised the Commission to issue a delegated act laying down requirements for a safety element which must include the packaging of medicinal products for which a prescription is required and the procedure for checking the authenticity of a medicinal product. In particular, Commission Delegated Regulation 2016/161/EU is not transposed into national law and is directly applicable in all EU Member States. It shall apply from 9 February 2019.
In principle, the marketing authorisation holder is obliged to designate the designated medicinal products as a safety feature and the marketing authorisation holders of the medicinal products concerned must establish and manage a register used to verify the authenticity or deactivation of the specific identifiers of medicinal products placed on the market in a Member State. The register must enable the competent authorities of the Member State (SEC, MZ SR) to access the register and the information stored therein.
The Director General of the Department of Pharmacy and Drug Policy MUDr. Peter Musil, MSc. said that MZ SR will deal with this problem, will negotiate with representatives of SUKL. It is necessary to determine who is the national competent authority. The AIFM shall ask its lawyers for an independent legal view of the problem. MZ SR sees no compelling reason that the system for verifying the authenticity of medicinal products is not in place.