Daronrix (Whole virion, inactivated, containing...) – Conditions or restrictions regarding supply and use - J07BB01

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

Sächsisches Serumwerk Dresden (SSW)

Zirkusstraße 40

D-01069 Dresden

Germany

Name and address of the manufacturer responsible for batch release

Sächsisches Serumwerk Dresden (SSW)

Zirkusstraβe 40

D-01069 Dresden

Germany

B.CONDITIONS OF THE MARKETING AUTHORISATION

•CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

Medicinal product subject to medical prescription.

Daronrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Daronrix takes due account of the officially declared pandemic strain.

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

Not applicable

•OTHER CONDITIONS

Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.

The MAH commits to performing the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan.

PSUR submission during the influenza pandemic:

During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 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 Periodic Safety Update Reports 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 (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:

Frequency of submission

-The clock will start from the first Monday after shipment of the first batch of vaccine.

-First data-lock point is 14 days later.

-Report submission is no later than day 22 (i.e. the following Monday).

-Reporting to be fortnightly for the first 3 months of the pandemic.

-Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly intervals.

Format

The report shall include the following Tables of aggregate data using the agreed templates:

1.Fatal and/or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports

2.Adverse Events of Special Interest (PTs)

3.Serious unexpected reactions (PTs)

4.All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 18-60 years, >60 years

All events occurring in pregnant women

5.All events reported by patients that have been entered into the database by data-lock point

6.A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.

Presentation of data will take into consideration the following recommendations:

-Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures and will only form part of the report if an issue of concern arises.

-All tables will be based on number of events (presented on PT level, sorted by System Organ Class [SOC]) and not number of cases.

-Tables 1 to 4 will be based on events reported from healthcare professionals only.

-In Tables 1 to 5, numbers will be provided for events received during the reporting period and cumulatively.

-All tables will be based on generic and not product-specific data. Product-specific data can be evaluated during signal work-up.

-A measure of relative reporting rate of signals for each reported PT should be provided if possible (e.g. Proportional reporting ratio [PRR], Information Component [IC)] or the Empirical Bayesian Geometric Mean [EBMG]; this is not mandatory as all MAHs do not yet have this capability.

-No line listings are required – these can be provided in signal evaluation reports as necessary.

A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided. All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.

A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:

i)EU member states for the reporting period by batch number,

ii)EU member states cumulatively and

iii)the rest of the world

Risk Management plan

An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.

C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER

The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.