THE REPUBLIC OF THE SUDAN, MINISTRY OF HEALTH THE BOARD OF PHARMACY, KHARTOUM, SUDAN.

REQUIREMENTS FOR REGISTRATION OF FOREIGN DRUG MANUFACTURING COMPANY

Name, address and type of the foreign company.

Name and address of local licensed local agent.

Copy of agency agreement certified by the Registrar of Companies

The manufacturing license (photocopy) for the company to manufacture pharmaceutical products for use in the country issued by the health authority in the same country.

Valid Statement of Licensing Status of Pharmaceutical Product (SLSPP) conforming to the format recommended by the World Organization, issued by competent certifying authority in the of origin authenticated, certified and stamped by Sudan Emt country of origin.

Valid GMP certificate issued by competent certifying authority country of origin authenticated, certified and stamped by Sudan Embassy in country of origin.

List of other divisions, subsidiaries etc. of the Mother Company their full address.

Other countries where the company is registered confirmed photocopies of the certificates of registration in those countries.

Full information and details about the pharmaceutical including at least the following information:

Name and address of the drug manufacturing plant(s).

Date of establishment.

Name and address of both Chairman of Board of Directors and Managing Director of the company.

Value in US $ of local sales of products manufactured in the during previous 12 months.

Value in US S of exported products manufactured in the plan names of importing countries during previous 12 months.

Products other than pharmaceuticals manufactured in that factory.

Layout plan of the factory, indicating location and floor area buildings and facilities.

List of all technical full-time staff of the factory, their posts and qualifications (Name : Post': Qualifications ).

List of lines and types of production.

List of major equipment.

Evidence of any internationally recognized awards or certificates.

Excellence or compliance with international standards, e.g. ICO 9001.

List of main research studies performed by the company during the last 5 to 10 years.

Pharmaceutical products released to the market based on the research.

Any other useful information about the company, its manufacturing plants and their products.

Fill in official forms, if any, are required.

Company Master file is required.

Dr. Salah edelin Abd Elrahman
Chairman, Committee for Registration of
Pharmaceutical Products for Human Use.

@Copy right 2002-2003 Embassy of the Republic of Sudn, New Delhi, India. Contact us. Designed and Developed by IANS Solutions

THE REPUBLIC OF THE SUDAN, MINISTRY OF HEALTH
THE BOARD OF PHARMACY, KHARTOUM, SUDAN

GENERAL REQUIREMENTS FOR THE REGISTRATION OF
PHARMACEUTICAL PRODUCTS

General Requirements for the Registration of Pharmaceutical Products

Introduction
According to the Pharmacy and Poisons Act it is an offence to manufacture, import, sell, offer for sale any pharmaceutical unless registered under the provisions of the Act, and regulations directives issued under the Act. So all applicants for registration of pharmaceutical products should be familiar with all such provisions and requirements issued by the Federal Board of Pharmacy. Directorate General of Pharmacy in the Federal Ministry of Health, the executive arm of the Board.

Pharmaceutical products submitted for registration should be manufactured in a registered plant. The criteria for registration of a pharmaceutical product are:

Need (health or market need)
Efficacy.
Safety.
Quality.
Advantage over similar registered products.
Price.

Genera! Rules to Applicants for Registration of Pharmaceutical Products:

The applicant can receive application form for registration of pharmaceutical product from the DGOP.

Applications for registration should -be submitted to the DGO according to the time schedule specified by the Directorate.

The applicant should be:

Holder of a valid wholesales pharmaceutical license and an agreement with the manufacturer.

A public sector establishment authorized by the Pharmacy and Act to deal with The applicant should fill two copies of the prescribed applicant in typewriter and should not overlook any information require part of the form. The prescribed duty stamps should be fixed first copy of the form. The applicant should also pay the prescribed application and registration fees and attach the receipt to the application form.

The form certifying the accuracy of documentation and information submitted for registration should also be filled by typewriting signed by responsible person specified by the applicant.

The applicant should present with the application form, these documentation and samples (as shown in registration requirements). All documents should be in English and/or Arabic.

A general synopsis should be submitted with the application it should cover all aspects of the documentation with reference to actual documents in a reference list. The general synopsis should provide a concise review of the information required by the about a pharmaceutical product to enable it to consider the for registration. The general synopsis should be an accurate the information in the manufacture full data file. Claimed about registered products should be shown.

Application for registration is accepted only for products produced in registered manufacturing plants.

Any incomplete or incorrect documents will not be accepted.

Any documents not properly arranged and filed will not be accepted.

Additional requirements for locally manufactured pharmaceutical products:

Special temporary pre-registration approval is required for local manufactured products, which enables the manufacturer to production of new pharmaceutical product for final registration applicant should submit the following documentation.

Fully filled prescribed application forms in three copies and overlook any information required in any part of the form. The prescribed duty stamps should be fixed to the first copy of the form.

Composition formula showing amount and specification for ingredient and purpose for its use.

Proposed method of manufacture.

Proposed method of analysis.

Specifications of the finished product

Protocol for certificate of analysis.

Protocol for stability studies are required.

Method, type and material of packaging including pack sizes description of the inner and outer package.

Draft of the product pack insert.

II. Registration Requirements:
The registration file submitted should include the following documents.

A Certificate of a Pharmaceutical Product (CPP)
Application for registration

Provide a WHO type Certificate of a Pharmaceutical Product issued under WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce.

The Certificate of the Pharmaceutical Product should be issued by competent authority in the exporting country as notified to authenticated and stamped by Sudan Embassy in country of

Date of introduction into the market in country of origin

The composition formula in the Certificate of the Pharmaceutical Product should show A the active and inactive ingredients.

The composition formula should be the same in country of origin

Registration licensing or authorization in other countries
Provide a list of the countries in which this product has been license for marketing. State for each.

The restrictions on sale or distribution

Container/closure system.

Photocopy of the certificate of registration in each of these countries.

Composition formula
Provide complete composition and quantitative formula of that with justification and purpose of use of each ingredient with mentioning to reference book, which shows allowance for used ingredient for that purpose. This should show unit dose form batch formula.

Compatibility of active and inactive ingredients and their effective product physicochemical properties should be shown.

Properties of the Active Pharmaceutical Ingredients
Provide at least the following information:

Active ingredient(s) by international non-proprietary names generic or chemical name and their source(s).

Chemical data on the active ingredient(s) chemical structure solubility of active ingredient in water and other solvents such as ether, ethanol, acetone and buffers of different, pH, and other physicochemical properties

Structural formula (constitutional and empirical), molecular\of infrared, ultraviolet spectra.

Active ingredient present in the form of salts or hydrate should be described quantitatively by their total mass and by the mass active moiety of the molecules.

Information on the chemical stability of the active pharmaceutical ingredient and physicochemical stability of relevant.

Name and address of manufacturer of Active Pharmaceutical Ingredient(s) (API) including any alternative manufacturers. Foreign site attach a GMP certificate issued by the drug control authority.

Specifications for the Active Pharmaceutical Ingredient
Provide a list of tests and limits for results for the active pharmaceutical active ingredient(s), including test methods in sufficient details.,

Provide the results of the methods of the assay of the (API) impurities.

If the ingredient is tested on the basis of a monograph in pharmacopoeia, it is sufficient to provide a copy of the monograph together with any test methods referenced but not duplicate monograph.

Provide details of any specifications additional to those in the pharmacopoeia.

Specifications for inactive ingredients
Provide quality control specifications, certificate of analysis of materials.

Provide a list of tests and limits for results for each experiment (solvent, liquid to adjust pH, coating materials, capsule shell imprinted on the dosage from) including test method.

If the ingredient is tested on the basis of a monograph in a pharmacopoeia, it is sufficient to provide a copy of the monograph together with any test methods referenced not in the monograph.

Provide details of any specifications additional to those in the pharmacopoeia, including microbiological limits for materials origin.

Manufacturing procedure for the finished product:
Provide a detailed method of manufacturing procedure for the product, including packaging and showing all materials used manufacturing process even if they do not appear in the final

In-process control procedures during manufacturing of the pharmaceutical product. Description of the finished product:

Give a detailed visual description of the finished product and packaging. Specifications of the finished product:

If the Pharmaceutical product applied for registration is including pharmacopoeia, its specification should be the same as that of latest edition of that Pharmacopoeia.

Provide a list of tests and limits for results for the finished pharmaceutical product details of test methods. If the ingredient tested on the basis of a monograph in a pharmacopoeia, provide copy of the monograph in that pharmacopoeia, together with methods referenced but not duplicated in the monograph.

Provide details of any specifications additional to those in the pharmacopoeia. Provide both release and expiry limits for re

Method of analysis of the finished product:

Provide a detailed method of analysis of the finished product determine its compliance with quality specifications (identification of active ingredient(s) of the finished product, purity, uniformity in performance, etc.). Difference between the factory method latest pharmacopoeial method should be justified.

Provide the results of validation of the assay method for product formulation. For pharmacopoeial method provide data which demonstrate that the method is applicable to this formulation.

Containers/closure system(s) and other packaging:
Give a detailed description of the container/closure system(s) including any liner or wading.

Provide details of the composition of each component.

Describe other (e.g. outer) packaging, and state what materials are made from.

Provide the specifications for any part of the container/closure system(s), which comes into contact with the product, or it protective, cover.

For parental products, packaging components that will at and come into contact with any part of the product must comply requirements specified by the BP, USP, or EuP.

Provide information and data about the stability of the container packaging materials to the product storage conditions.

12. Certificate of analysis of the finished product:
Provide original certificate of analysis of the same batch sub registration with batch number, manufacturing and expiry date and stamped by the quality control laboratory of the factory headed paper.

13. Describe package size
Stability data (according to WHO protocol)

Provide the results of stability testing of the formulation in the proposed marketing pack. Results should include physical as chemical tests.

Data should also be provided on the product's stability during a processing prior to use that may recommended on the latest product information, such as reconstitution of a powder, dilute injection, or dispersion of a tablet.

State the proposed shelf life with justification in terms of the stability testing, and the difference between release and specifications.

State storage conditions for the finished product.

Complete data and information about degradation products submitted.

With respect to both locally manufactured or imported product additional stability studies are required whenever major modifications are made to formulation, manufacturing process, packaging of preparation.

Conditions used for accelerated and ongoing stability studies follows:

Type of stability . Storage Temperature C Relative humidity % Duration studies (months) Accelerated ongoing stability studies (Plus-minus) 2 (plus-minus) 5 Minimum 15. Product package insert 15.1 the package insert must be written in clear and understate terms for both prescriber and patient. 15.2 The package insert should be at least written in an English or Arabic language(s). 15.3 Thirty copies of the product pack insert should also be with the application forms. 15.4 Certificate authenticated, certified by competent authority confirming that all information in the insert should be the same as that in that country. 16. General information about the pharmaceutical product package insert: This should include at least the following: 16.1 Name of the pharmaceutical product, generic and scientific name. 16.2 Different dosage forms and strength available for this pharmaceutical product. 16.3 Number of doses of the medicinal product in case of more than one pharmaceutical dosage form or strength. 16.4 Route of administration. 16.6 Main therapeutic group. 16.7 Indications and dosage regimen. 16.8 Contraindications, warning, precautions and drug interactions 16.9 Use in pregnancy and other special group of patients. 16.10 Adverse effects. 16.11 Overdose, signs, symptoms and treatment. 17. Sample and lablel: 17.1. Labeling of the outer pack should include at least following information: 17.1.1. The name of the pharmaceutical product. 17.1.2. Name of the active ingredient(s) showing the amount of present in a dosage unit. 17.1.3. Specification of active ingredient(s) 17.1.4. Package size for retail sale (number of dosage units, weight and description of unit). 17.1.5. Registration number of the pharmaceutical products (if registered) 17.1.6. Pharmaceutical dosage form. 17.1.7. Storage conditions and precautions. 17.1.8. Manufacturing and expiry date and batch number (should be in an uncoded form). 17.1.9. Warnings or precautions that may be necessary. 17.1.10. Others (measuring unit,.) 17.1.11. The name, country and address of the manufacturer 17.1.12. Legal status for distribution purposes (e.g. to be distributor on prescription onlv) 17.1 13. Package insert 17.1.14. Method of administration and the route of administration not for oral use. 17.1.15. Name of excipients to be of a safety concern for some patients or known to have a recognized action or effect. 17.2 Labeling of the inner (primary) pack should include at least the following information: 17.2.1 . The trade name of the pharmaceutical product and form. 17.2.2. Name of active ingredient(s) showing the amount of present in a dosage unit. 17.2.3. Specification of the active ingredient(s). 17.2.4. Manufacturing and expiry date and batch number. 17.2.5. The name and country of the manufacturer. 17.2.6. Route of administration, (if not for oral use). 17.2 6. 1 . Package size for retail sale, (number of dosage units, volume or weight per pack) except for tablets, capsules, loze powder for injection and suppositories (rectal and vaginal) 18. Price Provide the following information. 18.1. Proposed C&F price for registration in Sudan. The specification of entry should be indicated. 18.2. Wholesale and retail price in country of origin (certified authenticated and stamped from the competent authority in origin). 18.3. Whole sale price in other countries including neighbouring countries to Sudan and African countries. 18.4. Proposed retail price for registration in Sudan. 19. Dispending Category 19.1 Indicate dispending category (proposed method for distribution in the country of origin with justification of that categorization (Over the Counter), pharmacy only, hospital only or prescribed. 20. Withdrawal of product from markets 20.1. Provide a list of all countries whore the product has been withdrawn from the market or where the application for market has been rejected or withdrawn by the applicant, state the reason case. 21. Efficacy report: 21.1. For pharmaceutical specialists submit detailed report of efficacy studies carried out on the product. 21.2. For generic product submit detailed documentations of equivalence studies on the product in accordance to WHO recommendations, stamped and authenticated from the competent certifying authority in country of origin. This is required only 1 attached list. 22. Claimed advantage: 21.1. Claimed advantage over the registered products should be shown and supported by reference to randomize, controlled, comparative trials. Details of these trials should be given in an appendix. 23. Samples of actual product and/or Reference Stand Substance: 23.1. The Registration Department will request only one sample of actual products with document for approval. The remaining and Reference Standard will be requested after approval. 23.2. The number of samples required for each dosage form on Table (1) and should be accompanied by the certificate of 23.3. A quantity of Reference Standard Substance, which is for testing at least TEN samples, should be submitted in an air tight, light resisting container and clearly labeled with the name, concentration, manufacturing date, and expiry date, batch number, storage conditions. An extra quantity should be supplied, if required. 23.4. Samples of any other ingredient, that can be expected importance in the quality control of the specialty, should also be submitted in sufficient amount for retesting at least TEN samples. Note: If special requirements must be imposed on the storage of samples of Reference Standard are needed, their storage container should be written on the label of the inner and outer container. III. Special requirements for specific dosage forms l. Tablets: - appearance, colour, shape, friability, hardness, uniformity, with its specification, uniformity or thickness and diameter with pecilication, moisture and dissolution in full details. 2. Capsules: - appearance, moisture,' colour, shape, brittleness, dissolutic description of appearance and the colour of the filled materials, uniformity of weight with its specifications. 3. EmuIsions: - appearance, colour, odour, pH, viscosity. It is recommended that a heating - cooling cycle to be employed between 4-45C. 4. Solutions: - appearance, colour, odour, clarity of solution, pH 5. Suspensions and powder for suspension - appearance, precipitate and sedimentation rate, colour, odour, cloudiness particle size, disperability, redispersibility, suspended particle size, colouring matters, flavour used and pH. - Strength through the recommended storage period before reconstitution for powder of suspension. 6. Syrups and Elexirs: - description of colour, odour, taste and appearance, etc. pH specifications, refractive index with its specification, specific viscosity with specification, colouring matters, flavour and preservatives used. 7. Dry powder of external use: - appearance, colour, odour, and moisture content. 8. Ophthalmic, Otical and Nasal preparations: - description, appearance, colour, clarity, viscosity, uniformity, volume, particle - size specification and pH. - Preservative on lable (for ophthalmic preparations). 9. Injectable preparations - type of container and sealing - appearance, colour, clarity of solution, uniformity of weight, preservative (if applicable) and pH. - Description of solution on reconstitution of powder for injection, stability and strength through the recommended storage per and after reconstitution of powder for injection. 10. Suppositeries: - appearance, shape, colour, uniformity of weight, disintegration, or melting time with specification. 11. Ointment, Creams and Gels: - appearance, colour, odour, consistency, viscosity, homogeneity, uniformity of weight, uniformity of content and water content determination. 12. Antiseptic and Disinfectants: - appearance, colour, clarity of solution and pH. - The concentration and recommended dilution for optimal - Microbial spectrum - Evaluation of bactericidal, fungicidal and bacteriostatic action. 13. Aerosol pharmaceutical: - uniformity of content (with limitation). - propellant used - active ingredient/propellant ratio - spray testing - leaking testing - pressure measurement IV. Additional requirements for pharmaceutical products containing new entities application 1. New entities should be registered in countries that have a advanced system for registration of new drug entities. Provide these countries and photocopy of registration certificate in these countries. 2. Reports on all pre-clinical and clinical studies should be sent to the Registration Department, including: 2.1. Toxicological data: - single dose toxicity, species used and route(s) of administration - repeated dose toxicity, species, dose, duration, numbers a methods of evaluation - reproduction toxicity, dose, species and numbers of animal studies of teratogenic and embryotoxic effects. - pharmacokinetic information to validate interspecies comparison toxicity 2.2. Animal Pharmacology: - Primary action relevant to the proposed therapeutic use. - General pharmacology on vital body systems. - Dose/concentration effect relationship of primary or generation W pharmacological action - Absorption, distribution, biotransformation and main routes elimination. 2.3. Clinical documentation Synopsis: 2.3.1 Clinical pharmacological studioes - Pharmacological action(s) of the drug in man. - Time course of effect of single and multiple doses. Dose-response relationship and concentration effect relation - Absorption, route of biotransformation, (if of pharmacology toxicological significance), routes of elimination. - Systemic bioavailability of products intended to have a system effect. 2.3.2. Therapeutic efficacy: - Controlled trials carried out to support each claimed indication - Dose range use, modification of dosage in special group, e.g. children, - the elderly or malnourished individual, patients, with other irreversible effects. - Interactions with other drugs like to be given concurrently. - Interaction with specific foods - Evidence concerning dependency potential - Has the drug been used in pregnancy? Is it excreted in bre Specific contraindications - Recommendations concerning treatment of overdose or antidotes. 2.4. Any other relevant scientific informations VI. Table (1): Size of Samples to be Submitted for Registration No. Dosage Form Number of sample (Unit) for QC lab Number of (Unit) for Committee 1. Tablets, capsules, lozenges, for dispensing in original pack to individual patient course of treatment 1 00 tablets, capsules or lozenges in original packs 15 packs 2. Tablets, capsules, lozenges large pack (100 tablets, capsules or more) 1 00 tablets, capsules or lozenges + 3 empty packages 150 tablets capsules or lozenges + empty pack 3. Syrups, oral suspension, emulsions, elixir, aerosols 10 bottles 15 bottles 4. Dry powder or granules in sachets 20 sachets 15 sachets 5. Injectable ampoules and individual dose vial 50 ampoules + 3 empty packages 1 5 ampoules empty packages 6. Multidose vials 50 vials + 3 empty packages 15 vials + empty package 7. Ointments, creams, eye drops (topical or ophthalmic) 10 tubes 15 tubes 8. Suppositories or vaginal tablets 100 suppositories or vaginal tablets 1 50 suppositories or vaginal tablets REQUIREMENT FOR REGISTRATION AND RE-REGISTRATION FOR MINOR CHANGES REGARDING COMPANIES AND DRUGS 1. CHANGE OF THE PACK/PACK SIZE AND/OR ADITIONAL PACK 1. Request for minor change 2 Prescribed form should be filled correctly by typewriting. 3. Five samples from each old and new pack 4. Photocopy of Certificate of Registration in Sudan 5. Proposed price for the new pack (retail & wholesale) 2. CHANGE IN THE INNER PACK 1. Request for minor change 2. Prescribed form should be filled correctly by typewriting. 3. Five samples from each old and new pack 4. Photocopy of Certificate of Registration in Sudan 5. Stability study for the pharmaceutical product in the new pack 6. Approval from health authorities in the country of origin for pack 7. Batch Certificate of Analysis 8. Proposed price for the new pack 3. EXTENSION OR CHANGE OF SHELF LIFE OR STORAGE | CONDITIONS 1. Request for changing shelf life or storage conditions 2. Prescribed application form should be filled correctly 3. Five samples from each, old and new names, labeled i 4. Batch certificate of analysis 8. CHANGE OF COMPANY NAME 1. Covering letter with explanations 2. Approval of health authorities in the country of origin for company name authenticated and stamped by Sudan Embassy, country of origin 3. New Certificate of Pharmaceutical product for the new company name issued by the health authorities in country of origin (as notified to WHO), certified by Ministry of Foreign Affairs, authenticated stamped by Sudan Embassy in country of origin. 4. Five samples from each, labeled with the new and old company name 5. Batch certificate of analysis. 9 CHANGE OF PRICE OF PHARMACEUTICAL PRODUCT 1. Request for changing price 2. Prescribed application form should be filled correctly 3. Justification for change of price should be explained. 4. Wholesale price in the country of origin and other countries required 5. Photocopy of certificate of registration in Sudan 10. CHANGE OF LOCAL AGENT OF A FOREIGN MANUFACTURER 1. New agency agreement with the new local agent 2. Termination of the previous agency agreement 11. RENEWAL OF REGISTRTION OF PHARMACEUTICAL PRODUCT 1. Specified application form should be filled correctly 2. Payment of renewal fees 3. Photocopy of Certificate of Registration in Sudan 4. Photocopy of last Certificate of Renewal of Registration in 5. Valid Certificate of Pharmaceutical Product issued by the authorities in country of origin (as notified to WHO), certified Ministry of Foreign Affairs, authenticated and stamped by Sudan Embassy in country of origin. 6. Submission of application thirty days prior to expiration date of Certificate of Registration on From (B,) N.B. If there is no Sudan Embassy in country of origin, the Registration Department will suggest an alternative. Dr. Saiah edelin Abd EIrahman Chairman, Committee for Registration of Pharmaceutical Products for Human Use © Copyright 2002-2003 Embassy of the Republic of Sudan, New Delhi, India Contact Us Designed and Developed by IANS Solutions