Article Contents
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
Germany
Name and address of the manufacturer responsible for batch release
Sächsisches Serumwerk Dresden (SSW)
Zirkusstraβe 40
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.
- Fendrix - GlaxoSmithKline Biologicals S.A.
- Infanrix penta - GlaxoSmithKline Biologicals S.A.
- Twinrix adult - GlaxoSmithKline Biologicals S.A.
- Pandemrix - GlaxoSmithKline Biologicals S.A.
- Ambirix - GlaxoSmithKline Biologicals S.A.
- Prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals - GlaxoSmithKline Biologicals S.A.
Prescription drugs listed. Manufacturer: "GlaxoSmithKline Biologicals S.A."
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
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 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
-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
Format
The report shall include the following Tables of aggregate data using the agreed templates:
1.Fatal and/or
2.Adverse Events of Special Interest (PTs)
3.Serious unexpected reactions (PTs)
4.All events occurring in the following age groups:
- Pandemic influenza vaccine h5n1 baxter ag - J07BB01
- Celvapan - J07BB01
Prescription drugs listed. ATC Code: "J07BB01"
All events occurring in pregnant women
5.All events reported by patients that have been entered into the database by
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
-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
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.
Clinical | During the pandemic, the applicant will collect clinical safety | Depending on |
| and effectiveness data of the pandemic vaccine and submit | and after |
| this information to the CHMP for evaluation. | implementation |
|
| of vaccine |
|
| when first |
|
| pandemic will |
|
| take place. |
Pharmacovigilance | During the pandemic, the applicant will conduct a | Depending on |
| prospective cohort study as identified in the | and after |
| Pharmacovigilance plan. | implementation |
|
| of vaccine |
|
| when first |
|
| pandemic will |
|
| take place. |
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