Guidelines for registration of pharmaceutical products. According to ...

Guidelines for registration of pharmaceutical products. 

According to the ministerial decree 302/80. 

Documents and materials required for registration and re-registration of a 

Pharmaceutical company and its products in accordance with ministerial decree. 

N.B: Legalized must be done by the following: 

I. Kuwait embassy/consulate in the country of origin and when it is not 

possible, by an authorized Arabian embassy/consulate in the country 

II. Arab chamber of commerce of the country of origin. 

III. Kuwait chamber of commerce. 

* * Legalized is applied to the affiliated branches too. 

N.B: file should be submitted in CTD format according to ICH guidelines. 

See annexe (1) 

1. Company registration: 

1.1. Legalized letter of appointment from company (Stating that the agent is the 

sole exclusive agent in Kuwait.). 

1.2. Original legalized Manufacturing License from country of origin for each 

manufacturing site issued from ministry of health in country of origin. 

1.3. Original legalized “Good Manufacturing Practice” (GMP) from country of 

origin. (Not older than 2 years) 

Page 1 of 11

1.4. Site master file must contain the following: 

1.4.1. General information & history of the company including registered 

1.4.2. capital & turnover for the past 3 years 

1.4.3. Layout and diagrams of manufacturing sites. 

1.4.4. Quality control unit & quality management. 

1.4.5. Personnel information including number of employees in each 

department and their qualifications. 

1.4.6. Premises & equipments which include manufacturing sites owned by 

company, manufacturing lines, and equipments. 

1.4.7. List of products manufactured by the company and exporting 

countries. 

1.4.8. Distribution problems, complaints, product defects and recalls from 

any authorities worldwide. 

1.4.9. Contract manufacturing information 

1.4.10. FDA, EMEA, GCC or any recognized global approvals for the 

company. 

* * * 


2. Product registration: 

2.1. Original legalized Certificate of pharmaceutical product (CPP) for 

each pharmaceutical product in accordance with World Health 

Organization (WHO) recommended format issued from ministry of 

health in the country of origin. See annexe (2) for detailed information 

about CPP 

2.2. Original legalized Price certificate issued from the country of origin, 

and showing the following: 

2.2.1. Ex-Factory price. 

2.2.2. Whole sale price in the country of origin. 

2.2.3. Public price in the country of origin. 

2.2.4. C & F unit price for Kuwait. 

2.2.5. C & F unit price for the GCC countries and retail price in UAE. 

2.3. Legalized declaration - for Innovators’ companies- of patent expiry 

date& patent no. of the innovator product from the country of origin, 

USA (if available in US) and EU (if available in EMEA) ,legalized by 

Chamber of Commerce and with supportive documents from patent 

office should be submitted according to the Ministerial Regulation No. 

675/1998, in order to reserve the rights of the innovator company. 

2.4. Certificate of composition, mentioning the active and inactive 

ingredient (excipients , preservatives , coloring materials, flavoring 

agents , etc.. ) with their quantities. 


2.5. Source of supply of all ingredients (active & inactive) 

2.6. Raw materials specification (Pharmacopeia reference.) 

2.7. Certificate of suitability for any ingredient from animal origin 

(TSE/BSE certificate) 

2.8. Alcohol content declaration See annex (3) 

2.9. Detailed Finished Product Specification and standards / (End of shelf 

life, Finished product specification), laid down by the manufacturer, 

with limits for the respective tests for each pharmaceutical product, 

together with its method of analysis in details. When the product is the 

subject of a monograph in the Pharmacopeia it is sufficient to refer the 

page, edition and name of the Pharmacopeia concerned if it is issued in 

Arabic or English, a photocopy of the page or pages referring to the 

product and an Arabic or English, translation is required. 

see annex (4) 

2.10. Reference standard of the active ingredients and related 

substances with certificate of analysis to be submitted with their 

specification in full detail to be used as standard in the assay and 

identification. It should be labeled by generic name and batch number, 

manufacturing date, expiry date, storage conditions and chemical 

potency. Reference standard of preservatives (if the product contains 

these preservatives) or any by- products (if any) should be submitted 

with the same label requirement of the standard. 


2.11. Quantities of samples of the product to be submitted with the 

documents should be in their original packs and have the same batch 

number to be registered should be made available to the 

Pharmaceutical & Herbal Medicines Registration & Control 

Administration. In amounts as requested to carry out analysis of the 

product according to the requirements of the specification and method 

of analysis. 

2.12. Certificate of analysis in full detail for the finished product (for 

the same batch to be registered). 

2.13. Batch manufacturing records to be submitted for the same batch 

of the product to be registered. 

2.14. The pack label: should be printed with: 

2.14.1. Name of the product. 

2.14.2. Name of the manufacturer and country of origin. 

2.14.3. Batch or lot number. 

2.14.4. Manufacturing date. 

2.14.5. Expiry date. 

2.14.6. Storage conditions. 

2.14.7. Name of the Pharmacopeia (for the Pharmacopoeial product). 

2.14.8. Above information on stickers is not approved / allowed. 

2.14.9. All information on sample label, container and package insert 

(leaflet) must be in English or in both English and Arabic. 

2.15. Leaflet should include the following information: 

2.15.1. Enclosed leaflet must be in readable text size, understandable 

language (English or English/Arabic), and ordered headings for ease of 


navigation, full and comprehensive information in consistency with 

Sm.P.C. 

2.15.2. Description; product name, strength, dosage form, active 

substance, list of excipients, warning about certain excipient such as 

lactose. 

2.15.3. Indication, use and Clinical pharmacology. 

2.15.4. Dosage and method of administration.( may illustrated with 

pictograms and symbols) 

2.15.5. Warnings and precaution.( boxed warnings maybe added at the 

top of leaflet) 

2.15.6. Contraindications. 

2.15.7. Use in specific populations. ( pregnancy, nursing mothers, 

pediatric, geriatric) 

2.15.8. Adverse reactions. 

2.15.9. Over dosage. 

2.15.10. Drug interaction /Laboratory test interaction. 

2.15.11. Drug abuse /dependence. 

2.15.12. Non clinical toxicology. 

2.15.13. Clinical studies. 

2.15.14. How supplies /storage and handling. 

2.15.15. Name &address of marketing authorization holder. 

2.15.16. Date of last revision 

2.16. Stability studies as per ICH guidelines for climatic zone III & IIV 

2.16.1. Batch Type and Size: 

2.16.1.1. Stability studies should be provided for three batches of the 

same formulation and dosage form in the container closure system 

proposed for marketing. 


2.16.1.2. Two of the three batches should be at least pilot scale (1) , the 

third batch may be smaller. 

2.16.1.3. Batch type and size should be mentioned in stability study 

protocol. 

2.16.2. Raw data of the study must be in tabulated form. 

2.16.3. Study conditions: 

2.16.3.1. . General case / non specific studies: 

Study Storage conditions Minimum time period at 

submission 

Long term 30 ºC ± 2 ºC / 65 ± 5%RH Complete shelf life. 

Accelerated 40 ºC ± 2 ºC /75 ± 5%RH 6 months 

2.16.3.2. Studies for products stored in refrigerator : 

Study Storage conditions Minimum time period at 

submission 

Long term 5 ºC ±3 ºC Complete shelf life. 


(1) Pilot scale batch: Batches of drug product manufactured by a procedure fully representative 

of and simulating that to be applied on a fully manufacturing scale. 

For solid oral dosage form this generally taken to be at a min. scale of one tenth of full 

production or 100,000 tablets or capsules, whichever is large 


2.16.3.3. Studies for products stored in impermeable containers (2) 

Study Storage conditions Minimum time period 

at submission 

Long term 30 ºC ± 2 ºC Complete shelf life. 

Accelerated 40 ºC ± 2 ºC 6 months 

2.16.3.4. Studies for products stored in semi permeable containers (3) : 


at submission 

Long term 30 ºC ± 2 ºC / 35 ± 5%RH Complete shelf life. 


2.16.3.5. Studies for products stored in freezer : 


At submission 

Long term -20 ºC ±5 ºC Complete shelf life. 

N.B: In absence of accelerated storage condition for drug products intended to be 

stored in a freezer , data from elevated temperature ( e.g 5 ºC ±3 ºC or 25 ºC ± 2 

ºC ) on a single batch should be conducted for an appropriate time period to 

support use of the drug outside the proposed label storage condition. 

(2) Impermeable containers: containers which provide a permanent barrier to the passage of 

gases & solvents ( e.g : sealed aluminum tubes for semi-solids , sealed glass ampoules for 

solutions ) . 

(3) Semi permeable containers: containers which allow the passage of solvent while preventing 

solute loss .e.g: plastic bags or low-density polyethylene (LDPE) pouches for large volume 

parenterals (LVPs), LDPE ampoules, bottles and vials. 


2.16.4. Stability study protocol and conclusion. 

2.16.4.1. Product shelf life and storage conditions should be in 

conclusion of stability study. 

2.16.5. Testing frequency : 

2.16.5.1. Every 3 months the first year , every 6 months the second year 

and then annual 

2.16.6. Bracketing (4) can be applied to studies of the same container 

closure system where strength, container size or fill varies while the 

other remains constant. 

2.16.7. Stability studies for utilization period (in-use period) for 

preparations in multi-dose containers should be submitted. 

2.16.8. Effect of light (If applicable ) 

2.16.9. Recommended description of labeled storage conditions : 

Storage conditions 

Storage statement on label 

Room temperature “ Store below 30 ºC” or “ Store below 25 ºC” 

Refrigerator 

“ Store in a refrigerator between 2 ºC and 8 ºC” 

Freezer 

“ Store in a freezer between -5 ºC and -20 ºC” 

N.B: Any changes or updates in stability condition or guidelines in ICH is 

applicable to MD 

(4) Bracketing : It is the design of a stability schedule such that only samples on the extremes of 

certain design factors ( e.g strength , container size or fill ) are tested at all time points as in a 

full design .The design assumes that the stability of any intermediate levels is represented by the 

stability of the extremes tested 


2.17. Pharmacological, toxicological, clinical & non clinical studies and 

reports of the product, with published papers from international 

journals as to the safety and clinical efficacy of the product. 

2.18. A signed commitment to provide Kuwait food and control with a 

post marketing surveillance reports and any safety reports or ADRs 

report which the company may receive from users or healthcare 

professionals. 

2.19. Pharmaceutically equivalent multi –source pharmaceutical 

product (generic) needs to conform the same standards of quality, 

efficacy and safety of the originator, several test methods are available 

to therapeutic equivalence: 

2.19.1. Bioequivalence studies in Humans. 

2.19.2. Comparative Pharmaco-dynamic studies in Humans. 

2.19.3. Comparative Clinical studies. 

2.19.4. In-vitro dissolution studies. 

Applicability of each of these four modalities is discussed later, See annexe (5) 

2.20. Biosimiler products require additional documents, See annexe (6 ) 

2.21. Any change in the name of the manufacturer, product, shape of 

pack, specifications, shelf life, composition or leaflet of the product 

should be handled with logical reasons or scientific explanations. For 

detailed types of changes and required documents, See annexe (7) 

2.22. All the ministerial decree regulations for the registration, release 

and inspection of human pharmaceutical products is applicable for the 

registration of veterinary pharmaceutical product. See annexe (8) 


2.23. Registration cancellation circumstances: 

2.23.1. If the product does not comply with the specification issued by 

the manufacturer or by the pharmacopoeial specification, the product 

will be cancelled. 

2.23.2. If the registered pharmaceutical product is not imported to 

Kuwait for the previous two years the product will be cancelled. 

2.23.3. As per the instruction from the manufacturer to cancel, the 

product will be cancelled. 

2.23.4. A product is liable to cancellation if the Pharmaceutical and 

Herbal Medicine Control and Registration administration come to 

know by any circumstances other than agent about any warning issued 

for a specific drug or manufacturing site by FDA,EMEA,WHO,GCC or 

any other International Health Forums. 

2.23.5. Liable to cancellation if the agent fails to renew the product 

registration. 

2.23.6. Pharmaceutical and Herbal Medicines Control and registration 

administration reserves the right to cancel the registration of the 

product if it fails to comply with this ministerial decree. 

2.24. Renewal of registration: 

2.24.1. Original legalized Certificate of Pharmaceutical product in 

WHO format 3 months prior to pharmaceutical product registration 

expiration. 

2.24.2. Summary of product characteristics. 

2.24.3. Long term and accelerated stability studies as per ICH 

guidelines.(Production batch) 

2.24.4. Finished product sample. 

* * *

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