Registration as a Manufacturer, Importer or Distributor
of Active Substances (Human Use)
1.1 / Company information
Registered Company Name:
Address:
Company contact:
Telephone/Mobile: / E-mail:
DUNS Number: / - -
1.2 / In case of person applying on behalf of the proposed registration holder
Name of the contact:
Address:
Contact details:
Telephone/Mobile: / E-mail:
1.3 / If different from 1.1, address for communications and/or invoicing
For advice or assistance please e-mail:
Registration as a Manufacturer, Importer or Distributor
of Active Substances (Human Use)
Section 2: Site Information
2.1 / Site Information
Site Name:
Address:
Company contact:
Telephone/Mobile: / E-mail:
DUNS Number: / - -
2.2 / Site Activities
2.2.1 / Manufacture / Active Substances / Excipients / Export
2.2.2 / Importation / Active Substances / Excipients / Export
2.2.3 / Distribution / Active Substances / Excipients / Export
2.2.4 / Storage and Handling / Storage and Handling Only
2.2.5 / Living animals are kept from which substance(s) used in the production of active substance(s) are to be derived.
2.2.6 / Materials of animal origin from which an active substance(s) are to be derived are kept.
Section 3: Site Information – Manufacturing Operations Active Substances
1. / Manufacturing Operations – Active Substances
2. / Active Substance (please complete a separate page for each substance)
Intended for use in:
EU authorised medicinal product / “Special” medicinal product / Export to a third country
3.1 / Manufacture of Active Substance by Chemical Synthesis / Special Requirements*
3.1.1 / Manufacture of active substance intermediates
3.1.2 / Manufacture of crude active substances
3.1.3 / Salt formation/purification steps (e.g. crystallisation, please specify below)
3.1.4 / Other (please specify below)
3.2 / Extraction of Active Substance from natural Sources / Extraction / Modification / Purification / Special Requirements*
3.2.1 / Extraction of substance from plant source
3.2.2 / Extraction of substance from animal source
3.2.3 / Extraction of substance from human source
3.2.4 / Extraction of substance from mineral source
3.2.5 / Other (please specify below)
3.3 / Manufacture of Active Substance using Biological Processes / Special Requirements*
3.3.1 / Fermentation
3.3.2 / Cell Culture (please specify cell type e.g. mammalian/bacterial below)
3.3.3 / Isolation / purification
3.3.4 / Modification
3.3.5 / Other (please specify below)
3.4 / Manufacture of sterile active substance (Sections 3.1, 3.2, 3.3 to be completed as applicable) / Special Requirements*
3.4.1 / Aseptically prepared
3.4.2 / Terminally sterilised
3.5 / General Finishing Steps / Special Requirements*
3.5.1 / Physical processing steps (please specify e.g. drying, milling, micronisation, sieving)
3.5.2 / Primary Packaging
3.5.3 / Secondary Packaging
3.5.4 / Other (please specify below)
3.6 / Quality Control Testing / Special Requirements*
3.6.1 / Physical / Chemical testing
3.6.2 / Microbiological testing (excluding sterility testing)
3.6.3 / Microbiological testing (including sterility testing)
3.6.4 / Biological testing
3.7 / Other Activities
3.7.1 / Other (please specify below)
* For categories for Special requirements see Section 3b - next page
Section 3a: Site Information – Manufacturing Operations of Active Substanceswith Special Requirements
Note: If you have selected any special requirements in Section 3, please check the appropriate category
on the table below. If the Other (7.) category applies, also provide the required text.
Products with Special requirements
1. / B Lactam Antibiotics
2. / Other highly sensitising antibiotics
3. / Live Cells
4. / Pathogenic Organisms (Biosafety Level 3 or 4)
5. / Radiopharmaceuticals
6. / Ectoparasiticides
7. / Other <Please specify as free text>
No. / 1. / 2. / 3. / 4. / 5. / 6. / 7. (Please include text)
3.1.1
3.1.2
3.1.3
3.1.4
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.3.1
3.3.2
3.3.3
3.3.4
3.3.5
3.4.1
3.4.2
3.5.1
3.5.2
3.5.3
3.5.4
3.6.1
3.6.2
3.6.3
3.6.4
Section 4: Site Information –Importation Operations Active Substances
4.1 / Active Substance
4.2 / Intended for use in:
EU authorised medicinal product / “Special” medicinal product / Export to a third country
4.3 / Third-Country Manufacturer
Company:
Address:
Company contact:
Telephone/Mobile: / E-mail:
Section 5: Site Information – Distribution Operations Active Substances
5.1 / List of all active substances for which distribution operations apply.
No. / Active Substance / EU authorised
product / “Special” medicinal product / Export to a third country
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Section 6: Site Specific Supporting Documentation
6.1 / Statement of the equipment and facilities available at the site.
6.2 / Statement, arrangements for identification & storage of active substance starting materials before and during the manufacture of active substances.
6.3 / Statement, arrangements for identification and storage of active
substances.
6.4 / Statement describing arrangements for ensuring the turn-over of stocks
of active substances.
6.5 / Description of arrangements for maintaining:
(i) Production records, including records of manufacture & assembly.
(ii) Records of analytical and other tests used to ensure compliance.
(iii) Records of importation.
(iv) Records of storage and Distribution.
6.6 / Description of arrangements for keeping reference samples of:
(i) Materials used in the manufacture of active substances.
(ii) Active substances.
6.7 / Advanced therapy medicinal products, outline of arrangements for maintaining records to allow traceability containing sufficient detail to
enable the linking of an active substance to the advanced therapy
medicinal product used in the manufacture of and vice versa.
6.8 / Details of any manufacturing, importation, storage or distribution
operations other than those to which the registration relates carried on by the applicant on or near the premises and the substances or articles to which those operations relate.
Registration as a Manufacturer, Importer or Distributor
of Active Substances (Human Use)
Section 7: Site Personnel
Site Name / Postcode
The following personnel are nominated to work at this site:
Production Manager/Supervisor/person responsible for manufacture
Name / MHRA Person Number
(if available)
Quality Controller/person responsible for quality control of active substances
Person who supervises importation, storage or distribution operations
Person responsible for any animals kept
Person responsible for the culture of any living tissue
Section 7: Site Personnel
Site Name / Postcode
7.1 / Person nominated to be named as:
Production Manager / Quality Controller / See 7.3 Supporting documentation.
Responsible for animals / Responsible for culture of living tissue
Supervisor Importation / Supervisor Storage / Supervisor Distribution
Nominated Person
Telephone/Mobile: / E-mail:
MHRA Person Number (If
Company:
Address:
7.2 / Employment Status
Permanent Employee / Consultant
If you are a consultant please give details of your availability.
How frequently will you visit?
7.3 / Supporting Documentation
Documentation / A copy of the nominee’s Curriculum Vitae is attached, including
qualifications and experience relevant to this application as well
as the name and job title of the person to whom they report.
Documentation / Statement of the authority conferred on the person responsible
for quality control to reject unsatisfactory active substances.
7.4 / Declaration
I confirm that the above particulars are accurate and true to the best of my knowledge and belief. I agree to be nominated as indicated.
Signed
(Nominated Person) / Date
Print Name
Signed (Applicant) / Date
Print Name
Medicines and Healthcare products Regulatory Agency /
Registration as a Manufacturer, Importer or Distributor
of Active Substances (Human Use)
Section 8: / Contract Laboratory Site Information – Manufacture only
Guidance:
/GoodManufacturingPractice/Guidanceandlegislation/index.htm#4
8.1 / Contract laboratory Site Information
Site Name:
Address:
Company contact:
Telephone/Mobile: / E-mail:
DUNS Number: / - -
The licence/authorisation holder has assessed the laboratory as fit for purpose.
8.2 / Quality Control Testing carried out by the site.
Microbiological: Sterility
Microbiological: Non-Sterility
Chemical/Physical analysis of finished products
Biological testing of finished products
Stability Testing on finished marketed medicinal products
Is the site involved in finished product testing?
Is this site involved in microbiological testing of finished products and/or raw materials?
Other (If none of the above, please specify)
8.3 / Letting and/or accepting contracts.
Applicant intends to be a contract acceptor (i.e. carries out testing partially/wholly for others).
Applicant intends to be a contract giver (i.e. uses external test houses for some/all testing).
Section 8: / Contract Laboratory Site Information – Manufacture only
Section 8B: To be completed by the nominated Contract Laboratory
I confirm there is a written contract/technical agreement is in place.
I hereby confirm the contract laboratory are aware they have been named and may be subject to inspection by the MHRA, a written contract/technical agreement is in place and the contract laboratory is in agreement and aware of what is expected of them.
To the best of my knowledge and belief the particulars I have provided in Section B of this form are correct, truthful and complete.
Signed / Date
Print Name / Job Title
Company
Registration as a Manufacturer, Importer or Distributor
of Active Substances (Human Use)
Section 9: Declaration
I/We apply for registration as a Manufacturer, Importer or Distributor of
Active Substances for Human Use.
4.1 The activities are to be only in accordance with the information set out
in the application or furnished in accordance with it.
4.2To the best of my knowledge and belief the particulars I have given in
this form are correct, truthful and complete.
Signed (Applicant) / Date
Print Name
Capacity in which signed
5.1 / Certificate of Incorporation (issued by Companies House or similar document for Partnerships/Sole Traders).
5.2 / Photo ID - A copy of a document which may be used to identify the
named person such as the information page from a passport or a photo
card driver’s licence.
5.3 / Proof of Residence – Photocopies of at least two recent (not older than three months) utility bills to confirm the residential address of the named person.
* Only required for companies not yet registered with the MHRA
*
The submitted information shall be made publicly available and shall be consultable on the following website:To return the registration form or for advice or assistance please e-mail:
Form 1 New(API)E – Cover V1.0