Aflunov (influenza virus surface antigens (haemagglutinin...) – Conditions or restrictions regarding supply and use - J07BB02

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers of the biological active substance

GSK Vaccines S.r.l.

Via Fiorentina, 1 – 53100 Siena

Italy

GSK Vaccines S.r.l.

Loc. Bellaria – 53018 Rosia – Sovicille (SI)

Italy

Seqirus Vaccines Ltd

Gaskill Road, Speke, Liverpool

L24 9GR

UK

Name and address of the manufacturer responsible for batch release

Seqirus Vaccines Ltd

Gaskill Road, Speke, Liverpool

L24 9GR

UK

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

•Official batch release

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be taken by a state laboratory or a laboratory designated for that purpose.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports (PSURs)

PSUR submission when AFLUNOV is used during an influenza pandemic:

During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation 726/2004/EC will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time. Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic. Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated. In addition, duration a pandemic, resources needed for an in-depth evaluation of PSURs in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.

In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the Marketing Authorisation Holder (MAH) shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the “CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic

and intended for use outside of the core dossier context” (EMEA/49993/2008), and any subsequent update.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

•Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

•At the request of the European Medicines Agency;

•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.