Overview
Pharmacovigilance and Regulatory Affairs services in Poland
In Poland, Insuvia supports pharmaceutical and biotech companies with tailored Pharmacovigilance and Regulatory Affairs solutions that comply with EU rules and Polish regulations. We help you navigate the country’s regulatory system efficiently, whether you are launching a new product or managing an existing portfolio.
Our services include analysis of national PV/RA requirements, provision of a local Qualified Person for Pharmacovigilance, and country-specific literature screening. In addition, we manage local variations and renewals and deliver continuous national regulatory affairs services to maintain compliance in Poland.
Services in Poland
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 Poland
Pharmacovigilance
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Is an LPPV Required in Poland?
Yes, Local Person for Pharmacovigilance is required in PL.
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LPPV Requirements
- Must be fluent in Polish;
- Must be a resident of or have registered office in the territory of Poland;
- Must be medically qualified or have access to a medically qualified person (such access must be appropriately documented);
- Must be sufficiently competent and appropriately qualified and trained for the performance of PV activities.
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References
According to the Article 36g of the Polish Pharmaceutical Law gave the right to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) may request MAHs to nominate a local contact person for PV in Poland. This was requested for all MAHs along with the announcement by the President of the Office of 1st August 2014.
Regulatory Affairs
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Local RA Person Requirements
Local RA role is not mandatory in Poland.
However, to proceed e.g. within national phases of variations, notifications or other changes based on CAP (Code of Admin. Proc.) smoothly, the local person for Regulatory Affairs is highly recommended. -
Other mandatory local roles?
- Local represantative is mandatory in Poland.
In Chapter 1 of the ACT of September 6, 2001, Pharmaceutical Law the Art.35a specifies that: the representative of the responsible entity (Marketing Authorization Holder, MAH) is a natural person or a legal person residing or having its registered office in the territory of the Republic of Poland, designated by the MAH to permanently perform its duties and powers in the territory of the Republic of Poland on the basis of a contract; - LSO is mandatory: a contact person for the supervision of the safety of the medicinal product, having their place of residence or registered office in the territory of the Republic of Poland, who reports to the person referred in the point above.
- Local represantative is mandatory in Poland.
Contact
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