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Transcript of letter Web view Supporting Documentation Certificate of incorporation issued by Companies House (or

letter

Application for new Manufacturer’s Authorisation for Investigational

Medicinal Products MIA(IMP) (Human Use)

Section 1 Company information

Registered Company Name:

     

Address:

     

Company contact person :

     

Telephone/Mobile:

     

E-mail:

     

Trading Style:

     

Communications and/or invoicing address (if different)

     

In case of person applying on behalf of the proposed registration holder

Name of the contact:      

Contact details:

Telephone/Mobile:

     

E-mail:

     

Application Date

     

Purchase Order Number

     

Checklist

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Section 1 - completed once per application.

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Section 2, 3 & 4 - one copy for each named manufacturing/importation site.

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Section 5 - one copy for each person to be named on the site signed and dated.

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Section 6 - one copy covers three named Storage and Handling sites.

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Section 7 - one copy for each named Contract Laboratory site.

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Section 8 - completed once per application, signed and dated.

Supporting Documentation

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Certificate of incorporation issued by Companies House (or similar).

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Curriculum Vitae information either completed or provided for any nominated person, Qualified Person, Quality Controller or Production Manager.

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Nominated Qualified Person has provided a certificate from a professional Institute.

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Signed Technical Agreements (where applicable) are available.

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Site Master Files are attached or available.

Do you have a pending/approved Wholesale Distribution Authorisation or other Manufacturing Authorisation

|_| Pending

|_| Approved

|_| N/A

For advice or assistance please email: pcl@mhra.gov.uk and please read the following useful information before you apply:

https://mhrainspectorate.blog.gov.uk/2017/01/05/helping-us-to-help-you/

Application for new Manufacturer’s Authorisation for Investigational

Medicinal Products MIA(IMP) (Human Use)

Section 2 Site Information

Site Name:     

Address:

     

DUNS Number:

            -                   -                        

Site Contact Person

Name of the contact:      

Telephone/Mobile:

     

E-mail:

     

Site Activities

Are the products for administration to human beings?

Yes

|_|

No

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Animal Human Origin products are present at this site?

Yes

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No

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Site Types

Manufacture

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Import

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Batch Certification

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Assembly and Packaging

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Export

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QC Testing

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Biological

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Storage and Handling (picking of goods)

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Other (Please specify)

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1. Manufacturing Operations – Medicinal Products

1.1

Sterile products

1.1.1

Aseptically prepared

(Processing operations for the following dosage forms):

Special

Requirement

1.1.1.1

Large volume liquids

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1.1.1.2

Lyophilisates

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1.1.1.3

Semi-solids

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1.1.1.4

Small volume liquids

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1.1.1.5

Solids and implants

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1.1.1.6

Other aseptically prepared products: (Please specify)

|_|

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1.1.2

Terminally sterilised

(Processing operations for the following dosage forms):

Special

Requirement

1.1.2.1

Large volume liquids

|_|

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1.1.2.2

Semi-solids

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1.1.2.3

Small volume liquids

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1.1.2.4

Solids and implants

|_|

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1.1.2.5

Other terminally sterilised prepared products: (Please specify)

|_|

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1.1.3

Batch certification of sterile products

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1.2

Non-sterile products

1.2.1

Non-sterile products

(Processing operations for the following dosage forms):

Special

Requirement

1.2.1.1

Capsules, hard shell

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1.2.1.2

Capsules, soft shell

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1.2.1.3

Chewing gums

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1.2.1.4

Impregnated matrices

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1.2.1.5

Liquids for external use

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1.2.1.6

Liquids for internal use

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1.2.1.7

Medicinal gases

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1.2.1.8

Other solid dosage forms

|_|

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1.2.1.9

Pressurised preparations

|_|

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1.2.1.10

Radionuclide generators

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1.2.1.11

Semi-solids

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1.2.1.12

Suppositories

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1.2.1.13

Tablets

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1.2.1.14

Transdermal patches

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1.2.1.15

Intraruminal devices (veterinary only)

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1.2.1.16

Veterinary premixes (veterinary only)

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1.2.1.17

Other non-sterile medicinal product (Please specify)

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1.2.2

Batch certification of non-sterile products

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1. Manufacturing Operations – Medicinal Products

1.3

Biological medicinal products

1.3.1

Biological medicinal products - Manufacture

Special

Requirement

1.3.1.1

Blood products

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1.3.1.2

Immunological products

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1.3.1.3

Cell therapy products

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1.3.1.4

Gene therapy products

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1.3.1.5

Biotechnology products

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1.3.1.6

Human or animal extracted products

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1.3.1.7

Tissue Engineered products (not applicable)

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1.3.1.8

Other biological medicinal products (Please specify)

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1.3.2

Biological medicinal products – Batch certification

Special

Requirement

1.3.2.1

Blood products

|_|

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1.3.2.2

Immunological products

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1.3.2.3

Cell therapy products

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1.3.2.4

Gene therapy products

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1.3.2.5

Biotechnology products

|_|

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1.3.2.6

Human or animal extracted products

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1.3.2.7

Tissue Engineered products (not applicable)

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1.3.2.8

Other biological medicinal products (Please specify)

|_|

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1.4

Other products or processing activity

1.4.1

Manufacture of:

Special

Requirement

1.4.1.1

Herbal products

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1.4.1.2

Homeopathic products

|_|

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1.4.1.3

Other (Please specify)

|_|

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1.4.2

Sterilisation of active substances/excipients/finished products

1.4.2.1

Filtration

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1.4.2.2

Dry Heat

|_|

1.4.2.3

Moist heat

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1.4.2.4

Chemical

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1.4.2.5

Gamma Irradiation

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1.4.2.6

Electron beam

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1.4.2.7

Other (Please specify)

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1. Manufacturing Operations – Medicinal Products

1.5

Packaging

1.5.1

Primary Packing

1.5.1.1

Capsules, hard shell

|_|

1.5.1.2

Capsules, soft shell

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1.5.1.3

Chewing gums

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1.5.1.4

Impregnated matrices

|_|

1.5.1.5

Liquids for ext