ProductLife Group Romania

1. Interaction with local HA

Whilst submissions for most procedures are done via the Common European Submission Portal (CESP), there are local and administrative procedures that require the presence of a local regulatory expert. Approvals, response to questions (RtQs), post approval commitments (PACs), spontaneous requests are released on paper and as such must be picked-up in person with the need of local initiation for these critical aspects of the submission.

2. Access

Price application – As part of the price approval application, the local Medicine Identification Code (Cod de indentificare a medicamentului – CIM) must be requested by the local RA, followed by the HA statement on product legal status.

Placement on the Romanian market/Discontinuation/MA withdrawal/Sunset Clause exemption requests

In all these cases, it is usually the in-country RA that communicates with the local HA, keeping the authorities notified about the status and progress.

Reimbursement/distribution/local HA audits/donations/special needs products/labelling exemptions

Marketing Authorization Holders (MAH) or local affiliates can benefit from the assistance that local RA provide across several critical regulatory procedures. This includes support for documents requested for reimbursement applications; informing the distributors about recent approvals or changes in packaging; participating in local HA audits; applications for donations; special needs products; and labelling exemptions.

Promotional materials

RA can prepare the Abbreviated SmPC needed for promotional materials; they can review and submit the materials for approval to local HA and address any questions. The local RA can also evaluate and advise on requests for changes and communicate directly with the HA for clarification and further details.

Industry associations

RA can assist the MAHs, and local affiliates engage with industry associations. The RA is able to review, assess and communicate the point of view on different initiatives discussed in the working groups of industry associations (for example, originators producers or generics producers).

3. Pharmacovigilance

RAs provide essential, legally, required support with local pharmacovigilance (PV) services or as local safety officers (LSOs), and they can monitor local medical literature. This support also covers direct to healthcare professional communications (DHCP letters) and communication with authorities on follow-up on safety issues.

4. Medical devices

As for medicines, the need for local vigilance services for medical devices is addressed by in-country teams, with local teams responsible for vigilance and local medical literature monitoring.

In combination with their extensive knowledge of the regulatory environment in Romania, our local teams are able to communicate fully with the stakeholders in Romanian. Our local regulatory teams enhance our PLG Global services, and through the PLG Romanian Team located in Cluj and Bucharest we enable companies to comply with the regulatory and pharmacovigilance requirements for medicinal products and medical devices in the Romanian market.