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mc8 Form

This document appears to be an application for registration of a medicine with a medicines control authority. It contains a 6-page form requesting information about the applicant, medicine details, ingredients and specifications, manufacturing process and quality control procedures. The form requests a schedule of active and inactive ingredients, their names, quantities, specifications and reasons for inclusion. It also requests specifications for any raw materials used in manufacturing but not present in the final product, and specifications for packaging materials. Additional appendices request a summary of the manufacturing process and details of analytical control procedures performed on raw materials, during manufacturing, and to ensure compliance with specifications, as well as full specifications for the medicine.

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themba
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
226 views

mc8 Form

This document appears to be an application for registration of a medicine with a medicines control authority. It contains a 6-page form requesting information about the applicant, medicine details, ingredients and specifications, manufacturing process and quality control procedures. The form requests a schedule of active and inactive ingredients, their names, quantities, specifications and reasons for inclusion. It also requests specifications for any raw materials used in manufacturing but not present in the final product, and specifications for packaging materials. Additional appendices request a summary of the manufacturing process and details of analytical control procedures performed on raw materials, during manufacturing, and to ensure compliance with specifications, as well as full specifications for the medicine.

Uploaded by

themba
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

Form MC 8

Page 1 of 6 pages
CONFIDENTIAL

MEDICINES CONTROL AUTHORITY

MEDICINES AND ALLIED SUBSTANCES CO NTROL ACT [CHAPTER 15:03]

APPLICATION FOR REGISTRATION OF A MEDICINE


(To be submitted in duplicate)
To be sent to the Director General, Medicines Control Authority, P.O. Box UA 559, Union Avenue, Harare or to be lodged at the offices of the
Director General, Medicines Control Authority, 106 Baines Avenue, Harare.
Samples and printed matter to be forwarded by post or by other means and carriage, customs duty and clearance to be paid and effected by the
applicant in all instances.
Particulars of Applicant:
Name ..
Business address
Postal address ...
Telephone number ...
Particulars of medicine:
Approved name (if any) (1) ...
Proprietary name (Trade mark), if any (2) ..
Title of patent (registered in terms of the Patent Act [Chapter 202] if any
Name of proprietor of patent
Number of Patent .
Is the patent still in force? YE S/NO*
The form in which the medicine is presented, and the colour thereof (3) ...
Name and address of principal .
Name and address of manufacturer

Country of origin
The strength of the medicine .
Classification (4) ..
Will the medicine be manufactured, partially manufactured, repacked or relabeled in Zimbabwe?

State who will complete the process of manufacture .


State address at which the certificate will be kept

I enclose the fee of .


I, the undersigned, hereby declare that all the information contained herein and in the appendices is correct and true.
Date ..

.
Signature of applicant
*Delete the inapplicable____________________________________________________________________________________________________
Notes I. 2. 3 and 4
GENERAL INFORMATION
1. If no name has been allocated to the medicine by an appropriate international body, the name which has been or will be submitted for approval
must be mentioned here.
2. Medicines which are not identical in composition or strength are not regarded as the same medicine, but application for registration of
medicines which vary only in strength may be made on the same form.
3. The form of preparation, i.e. capsules, ear drops, emulsions, eye drops, injections, ointments, solutions, suppositories, suspensions, tablets, etc.
and the colour thereof must be mentioned here.
4. The classification of the medicine as described in the Fifth Schedule of the Medicines and Allied Substances Control (General) Regulations,
1991.

Form MC8
Page 2 of 6 pages

APPENDIX I
Name of medicine ...
Name of applicant
The form in which the medicine is presented and the colour thereof ...

The following is a schedule of the


(a) active ingredients, giving their approved names, chemical names, structural formulae, specification and quantity in a dosage unit of the
medicine;
(b) inactive ingredients giving specifications and quantity and reason for inclusion, e.g., preservative, antioxidant;
(c) specification of any raw materials used in the manufacturing process and not present in the finished medicine; and
(d) specification of packaging material in immediate contact with the medicine.

Approved name

Chemical name and


structural formula (1)

Quantity per dosage


unit

Active or non-active

Specifications (2)

Reason for inclusion of


ingredient

Specifications of additional raw material (if any) (2) used in the manufacturing pro cess and not in the final product

Specification of packaging material (3)

NOTES

1. The chemical name must, where possible, be given in terms of the published list of an appropriate international body.
2. Reference to the following publications will, where applicable, be acceptable:
(a) British Pharmacopoeia;
(b) European Pharmacopoeia;
((c) Pharmacopoeia of the United States of America;
(d) Pharmacopoeia of Japan;
(e) International Pharmacopoeia;
(f) such other works of reference as may be approved by the Authority.
3. Where no specifications for raw materials and packaging materials exist this must be mentioned.

Form MC.8
Page 3 of 6 pages

APPENDIX II
Name of applicant
Name of medicine ...
The form in which the medicine is presented and the colour thereof ...

(a) A summary of the manufacturing procedure


...
...
...
(b) The analytical control procedures performed on raw materials including the microbial status where applicable.
...
...
(c) The analytical control procedures performed during the manufacturing process
...
...
(d) The analytical control procedures used to determine the compliance with specifications
...
. ..
(e) The full specifications of the medicine including microbial limits ..
...
...
...
(0 Data and reasoning on which the stability of the medicine is predicted ( minimum of three batches is required)

(g) The shelf life claim


(h) Copies of all records and batch data relating to a particular batch (preferably that of the sample submitted). This includes raw material
analytical reports, manufacturing and packing master sheets, in process control records, final product analytical report and authorization for
release and any other appropriate records. ...

Where appropriate, references to the publications mentioned in the notes to Appendix I, will be acceptable

FormMC.8
Page 4 of 6 pages

APPENDIX III
Name of applicant ..
Name of medicine .
The form in which the medicine is presented and the colour thereof .
..

1.

(a) Has the medicine been registered in the country of origin? YES/NO* [If YES a valid certificate of registration in respect of such
medicine issued by the appropriate authority established for the registration of medicines in the country of origin must accompany
misapplication.]
(b) Has an application for the registration of the medicine been made in any other country? YES/NO*
If YES, state details .

(c) Has the registration of the medicine been rejected, refused, deferred or cancelled in any country? YES/NO*
If YES, state full details
...
Do you intend to advertise the medicine? YES/NO*
If YES, state how and give details of proposed advertising and promotional materials
..
..
..

2.

Under what category do you envisage distributing the medicine? ...

*Delete the inapplicable

Form MC 8
Page5 of 6 pages

APPENDIX IV
Name of applicant
Name of medicine ...
The form in which the medicine is presented and the colour thereof ...

(a) The following particulars refer to the lexicological trials undertaken.


..
...
...
(b) The following particulars refer to therapeutic effects of the medicine
..
..
(c) The following particulars refer to the tests which have been performed on animals regarding the efficacy of the medicine and the purposes for
which it will be promoted, with special reference to the dosage and method of administration (pharmacological trials)
...
...
...
(d) The following particulars refer to the tests which have been performed as in (c) above on humans:
...
...
...
(e) The following are particulars of the purpose, mode of action, side effects, contra-indications of the medicine:
.
.
..
(f) The following data relating to the pharmacokinetics and the bioavailability of the medicine in humans and animals is attached.
(g). State details of medicine residue in species intended for human consumption .
.
..
(h) State details of withdrawal periods for species intended for human consumption
...
...
...

Form MC. 8
Page 6 of 6pages

APPENDIX V
Name of applicant
Name of medicine .
The form in which the medicine is presented and the colour thereof .

(a)

The following are references to literature about the medicine:


.
.
.
.

(b)

The attached are relevant documents concerning the medicine:


.
.
.
.

(c)

Twenty copies of the package inserts or draft package inserts and twenty labels or copies of packages are attached:
.

.

(d)

All proposed advertising and promotional material is attached:


.
.

(e) Samples have been submitted by registered post/by hand* to the Director - General:

.
.

*Delete the inapplicable

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