Overview
Pharmacovigilance and Regulatory Affairs services in Bulgaria
Insuvia supports pharmaceutical and biotechnology companies in Bulgaria with Pharmacovigilance and Regulatory Affairs services that meet EU legislation and Bulgarian national requirements. Our approach combines European compliance expertise with local regulatory insight to guide you through every stage of the product lifecycle.
We provide consulting on local regulatory requirements, assign a local contact person for PV, and carry out local literature surveillance for pharmacovigilance. Our team also manages regulatory submissions at the national level and maintains country-level regulatory compliance support in Bulgaria.
Services in Bulgaria
Local Affiliate Services with An Integrated Cross-Functional Expertise
Local Pharmacovigilance
- Local QPPV / Local Person for PV (LPPV)
- Local Literature Screening
- Local ICSR Management
- Local PV regulatory intellingence
- Implementation of aRMMs (Educational Materials, DHPC)
Local Regulatory Affairs
- Health Authority contact
- Professional advice and regulatory consulting
- New MAA & Product Approval
- Product life-cycle management
- Local Regulatory Intelligence
- Artwork review & management
- Promotional Materials review and approval
Market Access
- Regulatory Intelligence
- Pricing applications
- Consulting on national reimbursement strategy
- Reimbursement applications
- Price negotiations with national authorities
- Support with risk sharing agreements
- Support with early access programs (EAP, CUP, NPP)
QA & Compliance
- Stock management support (shortage/stock out, product recalls, quality issues)
- Management of product quality complaints (PQC)
- Consulting on local GDP requirements
- Management of serialization requirements, liaison with NMVOs
- Review of HCP engagement, HCP/events sponsorship disclosure
- Promotional Materials & Activities Compliance
Legal & Regulatory Context in Bulgaria
Pharmacovigilance
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Is an LPPV Required in Bulgaria?
Yes, the Local Person for Pharmacovigilance is required in BG.
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LPPV Requirements
The local PV person in Bulgaria must be established in the territory of Bulgaria.
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References
The Bulgarian law for medicinal products in human medicine in force since April 2007, last amendment from 22.12.2012, Article 191, Point 3. sets an obligation for the MAH to nominate local PV person on a national level in Bulgaria.
Regulatory Affairs
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Local RA Person Requirements in Bulgaria
RA role is not mandatory, but needed to fill in contact detail forms for MAs different types of procedure applications and direct contact/communication with the BDA. For submissions to authority, local language needed for SPC, PL and labelling. Launch and withdrawal must be notified, as well as upcoming stock-out situations and some specificities.
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Other mandatory local roles?
There are no other mandatory roles required.
Authorities
National Competent Authorities in Bulgaria
Contact
Contact us for more information
Contact type
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