12th Annual Regulatory Summit – speeches by Katarzyna Czyżewska and Dariusz Tarabasz

During the 12th edition of the Annual Regulatory Summit held in Warsaw on 26-28 February, Katarzyna Czyżewska and Dariusz Tarabasz are to give presentations.

26.02 - 2019 DRUG REIMBURSEMENT – CHALLENGES AND OPPORTUNITIES – Katarzyna Czyżewska

• drug reimbursement in the context of investment in Poland and research and development activities: can RTR (reimbursement development mode) change the reimbursement status for some applicants

• the new negotiating strategy of the Economic Committee and the list of drugs reimbursed as of January 2019: have the lists changed significantly after another round of repeated reimbursement decisions?
   
• risks inherent in excessive price pressure – are tools preventing excessive exportation effective?
   
• what else may change in drug reimbursement in the light of the National Drugs Policy 2018-2022?

26.02 - IMPLICATIONS OF A MEMBER STATE’S EU EXIT FOR THE DRUGS MARKET ON THE EXAMPLE OF BREXIT – Katarzyna Czyżewska

• Brexit’s impact on marketing authorisations issued under the centralised, decentralised, MRP and national procedures
   
• guidelines of the European Commission on the necessary changes to drug marketing authorisations / manufacturing in the context of Brexit

• change of the marketing authorisation holder and validity of reimbursement decisions in Poland; strategy to be adopted where the applicant is the MAH and where the applicant is a representative of the marketing authorisation holder
   
• Ministry of Health’s communique on Brexit’s implications for drug reimbursement - what is it about?

28.02 - LAW ON COSMETIC PRODUCTS AND ITS IMPLICATIONS FOR ENTREPRENEURS. DIRECTION OF CHANGES, NEW DUTIES, MONITORING OF ADVERSE EVENTS, PRACTICAL ISSUES. NEW LEGAL ENVIRONMENT – EVOLUTION OR REVOLUTION? – Dariusz Tarabasz

• new law on cosmetic products in practice – entrepreneurs’ new obligations on the cosmetic market
• principles of penal and administrative liability – a new approach to ensuring enforceability of laws and regulations

• facility registration – practical issues
• System for Notifying Serious Adverse Effects of Cosmetic Products

1. operating principles
2. practical issues
3. regulations governing personal data protection (GDPR)

• monitoring of adverse effects in cosmetics and pharmaceutical industries on a comparative basis
• principles of supervision over cosmetic products in the context of protection of trade secrets and amendment of the law on suppression of unfair competition (including specifically the amendment to the definition of a business secret – sourcing information vs. act of unfair competition)
• the inspector’s rights and obligations during inspection

1. inspection step by step
2. entrepreneur’s rights during inspection