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A-Variations required submission of application :

Variations that affect the pharmaceutical foreign products (human and veterinary) or their manufacturers are classified as follows:

 

1. Change in Marketing Authorization Holder (MAH).

2. Change in the manufacturing site of the finished product.

3. Changes in the composition formula.

4. Change in any part of the secondary/outer pack of the finished product.

5. Change in any part of the primary/ inner packaging of the finished product.

6. Change in the shelf-life of the finished product.

7. Change in finished product specifications.

8. Change in pack size of the finished product.

9. Change in the shape or dimensions of the pharmaceutical form (for solid dosage form).

10.  Change of the name / Modification of the address of a foreign Manufacturer.

11.  Changing or adding a new agency for a manufacturer.

 

B-           Variations not required submission of application:

For any change(s) other than the previously mentioned variations in (A),

A notification letter only from the manufacturer to be submitted to NMPB.       

The following documents should be taken into consideration when submitting any variation application:       

No

Change

Required Documents

1

Change in MAH:

Change in the name and/or address of the marketing authorization holder.

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

2

Change in the manufacturing Site

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

6.       Registration of the new manufacturing site or production line at the NMPB, if not registered.

7.       Original Certificate of a Pharmaceutical Product (CPP) from the relevant competent health authority in the country of origin legalized by the Sudanese Ministry of Foreign Affairs.

8.       Real time stability studies from the new manufacturing site for at least two pilot-scale batches and commitment letter to complete the stability studies to cover the shelf life must be submitted (must cover at least six months).

N.B.

If the change is related to Manufacturer responsible for quality control or the finished product release the stability study is not required. 

3

Changes in the composition formula of the finished product

(excipients)

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees

6.       Original Certificate of a Pharmaceutical Product (CPP) from the relevant competent health authority in the country of origin legalized by the Sudanese Ministry of Foreign Affairs.

7.       Real time stability studies for at least two pilot-scale batches and commitment letter to complete the stability studies to cover the shelf life (must cover at least six months).

8.       A certificate stating that the product is free from (TSE/BSE) and a Halal certificate if the source of the active, in active and/or any other substance within the product is of animal source. 

9.       Comparative table that clearly outline the change (current and proposed).

10.    For solid dosage forms, dissolution study for at least three batches of the finished product with the old composition formula and 3 batches with the new composition formula. (Unless the change is related to the coloring or flavoring agent).

4

Change in any part of the secondary/outer pack of the finished product.

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

5

Change in any part of the primary/ inner packaging of the finished product.

 

 

 

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

6.       Real time stability studies for at least two pilot-scale batches and commitment letter to complete the stability studies to cover the shelf life (must cover at least six months).

6

 

Change in the shelf-life of the Finished Product.

 

6.1. Reduction of the shelf-life of the finished product

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

6.       Justification for the reduction in the shelf-life from the manufacturer.

6.2. Extension of the shelf-life of the finished product

  1. Letter from the local agent.
  2. Copy of registration certificate of product in Sudan.
  3. Application form for variation (to be filled in by the manufacturer).
  4. Artwork (Three copies) and New samples (if possible).
  5. Required Fees.

6.     Recent real time stability studies covering the proposed shelf-life.

7

Change in the finished product specifications.

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

8

Change in pack size of the finished product.

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

6.       Real time stability studies for at least two pilot-scale batches and commitment letter to complete the stability studies to cover the shelf life (must cover at least six months).

7.       A declaration that material of the primary/inner package has not been changed from the previously approved one.

9

Change in the shape or dimensions of the pharmaceutical form (for solid dosage form).

1.       Letter from the local agent.

2.       Copy of registration certificate of product in Sudan.

3.       Application form for variation (to be filled in by the manufacturer).

4.       Artwork (Three copies) and New samples (if possible).

5.       Required Fees.

6.       Dissolution study of at least three batches of the finished product in the new form and three batches in the old form.

10

Change of the name / Modification of the address of a foreign Manufacturer

1.       A valid copy of the manufacturing license from the regulatory authority in the country of origin in which the new name or modified address of the manufacture is mentioned.

2.       Valid cGMP certificate from the competent authority in the country of origin in which the new name or modified address is mentioned, authenticated and stamped by Sudan Ministry of Foreign Affairs.

3.       A declaration from the regulatory authority in the country of origin that the manufacturer has renamed or modified its address only without any change in the manufacturing site.

11

Changing or adding a new agency for a manufacturer

1.      Valid Agency agreement with the manufacturer authenticated by the Registrar of Companies from the Ministry of justice.

2.      List of products in case of partial agency stamped by the Registrar of Companies from the Ministry of justice.

3.      Termination letter from the manufacturer to the previous agency.

4.      Copy of the contract agreement between the new agent and the manufacturer.

 

 

Secretariat General

National Medicines and Poisons Board