Guidance on procedures and administrative requirements for master files: Sample letter templates
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- Letter of access sample
- MF agent or third party authorization letter sample
- CEP attestation letter sample
- BSE/TSE declaration sample
- Statement of commitment sample
Letter of access sample
(Date)
Master File Administration Unit
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Dear Sir or Madam:
Re: Letter of Access - (Master File Name) MF # (YYYY-XXX) (or New Master File if a New Submission)
Please accept this letter as authorization for Health Canada to review (Master File Name, MF # YYYY-XXX) referenced by:
Applicant/Sponsor Name Street Address, State/Province, Country Postal Code
In support of their drug submissions, DIN applications or clinical trial applications filed with the Pharmaceutical Drugs Directorate, the Biologic and Radiopharmaceutical Drugs Directorate or the Veterinary Drugs Directorate of the Health Products and Food Branch.
Yours sincerely,
(Signature)
Note: Please do not include any reference to submission type/number or product lines/names in your letter of access. For CTAs, you may also include the name of the sponsor of the CTA, name of the CTA and protocol number.
MF agent or third party authorization letter sample
(Date)
Master File Administration Unit
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Dear Sir or Madam:
Re: Master File Agent Authorization/Authorization for a Third Party Filing on Behalf of (MF Holder Company Name) - (Master File Name) MF # (YYYY-XXX)
Please be advised that we have appointed (company name/name) to be our authorized master file agent/act as a third party Filing on our behalf for the Canadian market. (Company name/name) will be responsible for:
- filing MF related transactions
- handling deficiencies
- managing the payment of fees
- managing associated correspondence and
- filing updates and administrative changes
Yours sincerely,
(Signature)
CEP attestation letter sample
(Date)
Master File Administration Unit
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Dear Sir or Madam:
Re: Drug Substance - CEP # XXXXXXXXXXXXX
On behalf of [API manufacturer name/MF holder], I attest to the following:
- I authorize Health Canada to refer to the CEP along with Report A and the specifications authorized by EDQM.
- I attest that [API manufacturer name/MF holder] will provide Health Canada with a copy of the entire EDQM dossier and associated correspondence in electronic form on request from Health Canada.
- I attest that GMP for APIs will be applied commencing with the starting material authorized by EDQM.
- I attest that there have been no significant changes in the manufacturing method and controls following the granting of the CEP, or its last revision, by EDQM.
- I attest that any conditions/additional tests attached to the CEP by the EDQM and any tests and limits additional to those in the Ph. Eur. monograph required for the intended use of the substance will be applied to each batch of the drug substance destined for the Canadian market.
- I attest that the in-house method [insert reference to in-house method(s) not mentioned on the CEP has/have] been submitted to the EDQM and are used as described in the dossier submitted to EDQM.
- I attest that the API that will be produced for the Canadian market will be manufactured in a manner using a manufacturing process that is identical to the route evaluated by the EDQM. In addition, any in-process tests or tests of intermediates submitted to or requested by EDQM will be applied in the manufacture of the API destined for the Canadian market.
- I attest that the specifications provided to the applicant reflect the final set of API specifications and the in-house method(s) listed on the specifications which were submitted to and assessed by the EDQM.
Yours sincerely,
[Authorized representative name]
[Position title]
[API manufacturer name]
BSE/TSE declaration sample
(Date)
Master File Administration Unit
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Dear Sir or Madam:
Re: BSE/TSE Declaration for MF NAME, MF # YYYY-XXX (dossier ID: e/f########)
We [MF holder’s name] declare that product(s) manufactured at the facilities/sites listed in the above-referenced master file is/are not manufactured using any materials of animal origin that are susceptible to BSE/TSE contamination.
OR
We [MF holder’s name] declare that product(s) manufactured at the facilities/sites listed in the above-referenced master file is/are manufactured using any materials of animal origin that are not susceptible to BSE/TSE contamination.
OR
We [MF holder’s name] declare that product(s) manufactured at the facilities/sites listed in the above referenced master file is/are manufactured using materials of animal origin (either as starting material, reagent or processing aid) that are susceptible to BSE/TSE contamination.
Complete data on the risk of transmitting BSE/TSE has been provided in Section 3.2.S.2.3 Control of Materials or 3.2.P.4.5 Excipients of Human or Animal Origin of the application.
AND
We [MF holder’s name] declare that product(s) manufactured at the facilities/sites listed in the above-referenced master file are/are not susceptible to BSE/TSE contamination. (Type V)
Yours sincerely,
[MF contact person/authorized representative name]
[Position title]
Note: The statements outlined above are separated by the word “OR”. MF holder should declare the BSE/TSE risk by choosing the statement as appropriate.
Statement of commitment sample
(Date)
Master File Administration Unit
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Dear Sir or Madam:
Re: Statement of Commitment for MF name, MF # YYYY-XXX (dossier ID: e/f#######)
We, [MF holder’s name], certify that, to the best of our knowledge and belief, with reference to the application pertaining to [API NAME/MF NAME] manufactured in our plant at [LOCATION]:
- All the information and material included in the application and solicited information are accurate and complete, and that the summary documents correctly represent the information and material referred to in the application. No information is false or misleading and no omissions have been made that may affect its accuracy and completeness.
- The product is manufactured in accordance with the process described herein and each lot of the product released will conform to the specifications if tested by the methods described in the MF.
In addition, we agree to maintain the MF in order to keep the file open and active by updating the information contained in this document by submitting an “Update the MF” when significant changes to the MF should be submitted according to applicable guidance documents on post-NOC changes are made.
Yours sincerely,
[MF contact person/authorized representative name]
[Position title]
[MF holder name]
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