DOCUMENT SUBMISSIONS-RELEASE:

MONDAY – FRIDAY: 10,00 – 12.00 – document submissions
MONDAY – FRIDAY: 12,30 – 14.30 – document release

Authorisation, renewal, variations European procedure, variations national procedure, pharmacovigilance, clinical trials, clinical trial sites, authorisation for special needs, parallel import, advertising, educational material.

DOCUMENT RELEASE – PHARMACEUTICAL INSPECTION DEPARTMENT:

MONDAY: 13:00 -15:00
WEDNESDAY: 11:00 -13:00
FRIDAY: 10:00 -12:00