London, 23 October 2018

Application for an EMEA Certificate for a Vaccine Antigen Master File (VAMF)

Application Form

February 2005

APPLICATION FORM

This form is to be used for an application for a certificate for a Vaccine Antigen Master File (VAMF)submitted to the European Agency for the Evaluation of Medicinal Products in accordance with Commission Directive 2001/83/EC as amended.

NOTE: Please consult the “Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification” and the “Note for Guideline on the Scientific data requirements for a Vaccine Antigen master File”.

DECLARATION and SIGNATURE

Name of vaccine antigen[1]:

Person authorised for communication,

on behalf of the VAMF applicant*:

Applicant:

It is hereby confirmed that all existing data which are relevant to the quality of the antigen have been supplied in the VAMF dossier and that these data are identical to the relevant sections of the quality documentation of each linked MA specified in 3.1.

It is hereby confirmed that fees will be paid/have been paid according to the Community rules**.

On behalf of the Applicant

______

Signature(s)

Name

Function

Place and date (dd-mm-yy)

*Note: Please attach letter of authorisation for communication/signing on behalf of the VAMF applicant in Annex 4.3

**Note: If fees have been paid, attach proof of payment in Annex 4.1 - See information on fee payment in the Notice to Applicants, Volume 2A, Chapter 7.

1. TYPE OF APPLICATION

1.1This application concerns:

Application for initial EMEA certification for a Vaccine Antigen Master File

In the framework of a new MAA via the centralised procedure.

In the framework of a new MAA for a mutual recognition procedure.

In the framework of a new MAA for a national procedure.

Other[2].

Comment:


(Name of Co-ordinator 1) / 
(Name of Co-ordinator 2)

2.APPLICATION PARTICULARS

2.1Description of the vaccine antigen

2.1.1Name of the vaccine antigen

Note:Only one name should be given in the following order of priority: Ph.Eur., National Pharmacopoeia, common name, scientific name.

2.1.2Antigen storage details

2.1.2.1Container description

2.1.2.2 Proposed shelf life and storage conditions:

Attach antigen specifications in Annex 4.2

2.1.3Intermediate storage details (include details on all manufactured intermediates)

2.1.3.1Intermediate name[3],[4]:

2.1.3.2Container description:

2.1.3.3 Proposed shelf life and storage conditions:

Attach specifications for each named intermediate in Annex 4.2

2.2VAMF certificate holder and Contact person[5]

2.2.1Proposed VAMF certificate holder:

Company Name:

Address:

Country:

Telephone:

Telefax:

E-Mail:

2.2.2Person/company authorised for communication on behalf of the VAMF Applicant during the procedure:

Company Name of contact*:

Address:

Country:

Telephone:

Telefax:

E-Mail:

* If different to 2.2.1 above, attach letter of authorisation (Annex 4.3)

2.3Antigen Manufacturer(s)

2.3.1Manufacturer(s) of the antigen and site(s) of manufacture

Note:All manufacturing sites involved in the manufacturing process of the antigen should be listed.

Antigen:

Manufacturer Name:

Address:

Country:

Telephone:

Telefax:

E-Mail:

Brief description of manufacturing steps performed by manufacturing site(s):

Attach flow chart indicating the sequence of the different sites involved in the manufacturing process of the intermediates and antigen (Annex 4.4)

Where an antigen manufacturer has been inspected by an EEA country:

The following information should be provided in Annex 4.5 for each site:

- last inspection date by an EEA country (yyyy-mm-dd)

- name of competent authority which carried out the inspection

- type of inspection (pre/post-authorisation/special/re-inspection)

- categories of ingredient and activities inspected

- outcome:  positivenegative

2.4Qualitative and quantitative composition

2.4.1Qualitative and Quantitative composition in terms of the antigen:

Name of antigen* / Specific activity / Reference/
Monograph standard
1.
Name of other ingredient(s)*
(e.g. stabilisers) / Quantity[6] / Reference/
Monograph standard
1.
2.
3.
4.
5.

Note:* only one name for each substance should be given in the following order of priority:
Ph.Eur., National Pharmacopoeia, common name, scientific name. Do not specify residuals in

this section.

2.4.2List of materials of animal and/or human origin contained or used in the manufacturing process of the vaccine antigen or as other ingredients:

Are Tables A, B and C on materials of animal and/or human origin applicable to this antigen?

 No Yes

If yes, complete Tables A, B and C on materials of animal and/or human origin and attach in Annex 4.6

If a Ph. Eur. Certificate of suitability for TSE is available according to Resolution AP/CSP (99)4 of the Council of Europe attach it in Annex 4.7.

3MARKETING AUTHORISATIONS (granted or pending) to which the vamf certificate will apply

3.1Details of applications for Marketing Authorisation/Granted MAs in the EEA (including EMEA) to which the approved VAMF certificate will apply. Attach lists of linked products (authorised, pending[7], withdrawn/revoked) in Annex 4.8[8]

Note: if a particular MAH name and address is not identical to the name and address of the proposed VAMF certificate holder, a relevant declaration should be provided in Annex 4.9 that the VAMF applicant and the MAH belong to the same mother company or group of companies which share the same data package.

NoteIt is strongly advised not to initiate a VAMF certification when there are ongoing variations related to the content of the VAMF in the individual MA(s). If there are any on-going procedures which might impact on the assessment of the VAMF data in any specified linked Manufacturing Authorisation, detailed information should be attached in Annex 4.10

3.2Details of applications for the same antigen within marketing authorisation applications outside the EEA

Authorised

country:

date of authorisation:

invented name:

Pending

country:

date of submission:

invented name:

Refused

country:

date of refusal:

invented name:

reason for refusal:

Withdrawn/ suspended/ revoked

country:

date withdrawn/ suspended /revoked.:

invented name:

authorisation number (if applicable):

reason:

4. ANNEXED DOCUMENTS (where appropriate)

4.1Proof of payment

4.2Specifications (antigen and intermediates) for proposed storage conditions.

4.3Letter of authorisation for communication on behalf of the VAMF applicant.

4.4Flow-chart indicating the different sites involved in the manufacturing process of the intermediates and antigen

4.5Statement from the competent authority, which carried out the inspection of the manufacturing site(s)

4.6Tables A, B and C on materials of animal and/or human origin.

4.7Ph. Eur. Certificate(s) of suitability for TSE

4.8List of VAMF linked Products*

4.9Declaration that applicant and MAH belong to the same mother company or group of companies which share the same data package.

4.10Detailed information relating to any on-going procedures, which might impact on the assessment of the VAMF data in any specified linked Manufacturing Authorisation.

* See template in Annex 4.8

Table A:Materials of animal origin covered by the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products[9]

Antigen name:
Applicant:
Date of completion of table:
Name of material
Name and address of manufacturer[10]
Species and tissue from which material is a derivative
Country of origin of the source animals for the material cited
Do you have a TSE-Certificate of Suitability[11] for the material of animal origin? If yes, please put number and date of certificate and attach to part IA.
As antigen
Use
of
material / As reagent/ culture medium component used in routine manufacture
As reagent/ culture medium component used in establishment of new master cell banks[12]
As reagent/ culture medium component used in establishment of working cell banks
Starting material used in manufacture of antigen
Other, give details

Table B: Other materials of animal origin[13]

Antigen name:
Applicant:
Date of completion of table:
Name of material
Name and address of manufacturer
Species and tissue from which material is a derivative
Country of origin of the source animals for the material cited
Use
of
material / As antigen
As reagent/ culture medium component used in routine manufacture
As reagent/ culture medium component used in establishment of master cell banks[14]
As reagent/ culture medium component used in establishment of working cell banks
Starting material used in manufacture of antigen
Other, give details

Table C: Albumin and other human tissue derived materials

Antigen name:
Applicant:
Date of completion of table:
Name of Material
Supplier
Tissue from which material is a derivative
Country (-ies) where donation took place
Does the material have a Marketing Authorisation?
If yes, specify Member States(s) and MA number(s)
Use
of
material / As antigen
As reagent / culture medium component
Other, please specify
Annex 4.8

(Submission also in electronic word)

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List of VAMF <insert VAMF name > linked approved Marketing Authorisations

Common name of the Vaccine / Invented name(s) /
Country of authorisation
/ Marketing authorisation number(s), / Authorisation date
Add invented name(s) of this authorised vaccine / Add corresponding country where this vaccine is licensed / Add corresponding MA numbers / Add corresponding date of authorisation

List of VAMF <insert VAMF name > linked Marketing Authorisation Applications

Common name of the Vaccine / Invented name(s) / Country /
Reference Number
Add invented name(s) of the MAA.* / Add corresponding country where this MAA has been submitted / Add any corresponding reference number for the MAA, issued by the Competent Authority

* VAMF applications may be submitted in the framework of new MAAs [see Triggers 1, 2 and 3 of the “Guideline on requirements for Vaccine Antigen Master File (VAMF) certification”]. Such pending MA(s) which are submitted in parallel to the VAMF application, should be tabulated here.

List of Marketing Authorisations/MAAs, which contain the antigen to which the VAMF <insert VAMF name > data apply, which have been revoked/ withdrawn/refused.

Common name of the Vaccine / Invented name(s), / Marketing authorisation number(s) if relevant / Country and date revoked/ withdrawn/ suspended /
Reason

1/17

[1] The antigen name should be constructed by adherence, as far as possible, to the principles outlined for finished product vaccines in the CPMP/BWP/2758/02 Guideline on Pharmaceutical Aspects of the Product Information for Human Vaccines. If the applicant has/ will hold more than one VAMF for a particular type of antigen (e.g. two VAMFs for 2 diphtheria antigens from different sources), the applicant should include a distinguishing reference in the name.

[2] See section 4.1 Guideline on “Requirements for VAMF certification” Specify trigger for submission of a VAMF application and detail reason, as applicable, in the comment box.

[3] Information should be provided for each named intermediate

[4] Specify any intermediates stored for ≥ 48 hours

[5] VAMF Applicant and VAMF certificate holder must be the same.

[6]Quantity of other ingredients should be given in relation to the active ingredient e.g. /mg active etc. Ranges are acceptable.

[7] VAMF applications may only be linked to those MAAs which are submitted in parallel to the VAMF application.

[8] Templates for these lists are attached in Annex 4.9. This Annex should also be submitted electronically in word.

[9] Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products, Jan 2004 (EMEA/410/01 rev2) or any future revision.

[10] The manufacturer and not the supplier/broker of the material of animal origin should be mentioned. For the same material from different manufacturers, use a separate column for each manufacturer.

[11] From 1 January 2000, manufacturers of materials of animal origin can submit a dossier to the European Pharmacopoeia to obtain a Certificate of Suitability in accordance with the monograph: ‘Products at risk of transmitting animal spongiform encephalopathies’.

[12] Materials of ruminant origin used in the establishment of existing master cell banks should be included in Table B.

[13] Materials not covered by the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products, Jan 2004 (EMEA/410/01 rev2) or any future revision.

[14] Materials of ruminant origin used in the establishment of existing master cell banks should also be included in this Table.