SARAP zaslal v marci 2020 na ŠÚKL otázky k § 60, ods. 1, písm. i) bodom 8 a 9 zákona 362/2011, ktoré sa týkajú oznamovania sťahovania lieku z trhu v ostatných krajinách a hlásenia písomných reklamácií, spolu s príkladmi reklamácií, ktoré ste poskytli. V týchto dňoch SARAP dostal odpovede od ŠÚKL.

Oba dokumenty sa nachádzajú tu:

29.4.2020

Vážení členovia,
informujeme vás o spôsobe práce EMA počas najbližších týždňov:

Dear Industry Stakeholders,

In view of the rapidly changing situation in the context of the COVID-19 pandemic, I would like to inform you that, as of Monday, 16 March 2020, the vast majority of EMA staff members is working remotely. This measure is in line with the steps taken by the European Commission and aims to support the Dutch Government’s efforts to slow down the spread of COVID-19. Despite the reduction of the physical presence in the Agency’s premises to a minimum, EMA’s operations will be maintained. The new measure is currently planned to last until the end of April 2020 but may be further extended if the situation requires.

A limited number of staff will be present at the office to ensure continuity of critical business processes which have to be performed on site.

This measure follows our decision from last week to hold all meetings of the EMA Management Board, scientific committees and working parties, as well as stakeholder events virtually until the end of April 2020.

Our plans are being continually reviewed and we will update you as the situation develops.

.Thank you for your continued collaboration and for forwarding this information to your respective (affiliated) Members, as appropriate,

Once again, please not hesitate to contact me should you have any questions.

Yours sincerely,

Marie-Hélène

17.3.2020

Vážení členovia,
v roku 2020 sú aktivity SARAP plánované nasledovne:

Tím SARAP 

13.12.2019