1. Regulatory affairs service
support
Rayna Kostova
Regulatory affairs and PV expert,
MPharm
Medicaldevices
&
medicovigilance
Pricing and
Reimbursement
Rayna Kostova, Regulatory affairs and Pharmacovigilance services 1

2. Registration of new
medicinal products in
EU countries: national
MRP, DCP, CP
preparation of documentation, negotiation
with local Authorities and submission in
Bulgaria (other EU countries)
2

3. Variation procedures
acc. to EU legislation
preparation of documentation, negotiation
with local Authorities and submission in
Bulgaria (other EU countries)
Product information changes, labelling
and leaflet variations (acc. to QRD
template requirements)
3

4. Medical devices
registration/notificati
ons acc. to EU
requirements
preparation of documentation, negotiation
with local Authorities and submission in
Bulgaria (other EU countries)
Product information: label, leaflet text
translations, proof-reading for BG
4

5. Biocidal products
registration acc. to
national and EU
requirements
preparation of documentation (technical
dossier), negotiation with local
Authorities and submission in Bulgaria
(other EU countries)
Product information: label, leaflet text
translations, proof-reading for BG
5

6. Food for special medical
purposes, food supplement and
cosmetic products
registration/notifications acc.
to EU requirements
preparation of documentation, negotiation
with local Authorities and submission in
Bulgaria (other EU countries)
Product information: label, leaflet text
translations, proof-reading for BG
6

7. Price registrations and
reimbursement procedures
preparation of documentation, negotiation with local Authorities
and submission in Bulgaria (other EU countries)
Market competitors prices research, long
term pricing strategy with internal and
external price referencing (17 Ref.
countries for BG)
Positive Drug list procedure for
reimbursement by the National Health
Insurance Fund and the hospital budget
7

8. Pharmacovigilance and
Medicovigilance
services
Literature screening for ADR
ADR reporting to local Authorities in BG
PSUR and RMP submission
Service as a Qualified person for PV
(QPPV) for the country
Collecting and reporting AE for Medical
devices
8

9. Product complaint
management
Receive, process, report signals of
complaints for drugs, medical devices,
biocides, enteral nutrition products and
cosmetics
Plan and propose corrective and
preventive actions (CAPA), submit FSN,
perform recalls and report to Authorities
Maintain complete database with complaint
signals and CAPA performed acc. to
internal and legal requirements 9

10. Quality management
system (QMS)
Create and maintain a system of
relevant SOP for RA, PV, GDP acc.
to company requirements and local
legislation
Support company during preparation
and conduction of internal/external
ISO audits
10

11. GOOD DISTRIBUTION PRACTICE
(GDP)
License as responsible pharmacist of
local warehouse for medicinal products in
Bulgaria
Experience as warehouse manager acc. to
local BG legislation requirements
Compliance with EU Legislation changes
support
11