WISH TO EXPORT TO BAHRAIN
The agent or the company representative should provide the following documents for the registration of a pharmaceutical manufacturer or its site.
- Full profile of the Company including kinds and scope of activities.
- Number of manufacturing sites owned by the company and their addresses.
- The kind of legal and commercial relationship the company holds with these
- Manufacturing licence number and its date in country of origin
- List of all products marketed by the company
- Agency Contract
- GMP certificate from the health authorities in the country of the site
- Number of employees in the different sections and their qualification.
- Graphic design of the site and flow of manufacturing lines
- List of all products the site produces either on its vicinity, or through contract manufacturing with or for other marketing authorization holders (NIAH's)
- Clarification of the relationship with the MAH.
- Any inspection visit report by GCC health authorities or Arab Health Authorities, except for country of origin if it is an Arab country/site. Otherwise, a GMP inspection visit should be arranged.
Registration does not cover wholesalers and distributors. Marketing authorization holders should have a manufacture licence issued by the health authorities in country of origin.
In case of failure to meet GMP requirements after a GMP inspection visit, a 12-month period should elapse before reconsidering the case.
MOH authorities should be informed about any sale, merge, take or take over or any legal or commercial action concerning the company or its site within 90 days of the action.
The applicant should submit a description of the submitted documents as follows:
- Number of submitted files
- Number of samples submitted along with a brief description of these
- Full index of contents of the files
The files should contain the following:-
- A CPP form according to WHO certification scheme authenticated by health authorities in the country of origin. If, for any reason the certificate cannot be provided from that particular EU country than from any EU country where the product is marketed with clarification for the reason.
Legalization of this certificate by any GCC embassy is requited.
The CPP should contain the following:
- registration number in country of issue
- name and address of the applicant
- name of the country issuing the certificate
- name of the country for which the certificate is issued.
- name and address of the manufacturing Licence holder
- the proprietary name of the product if available.
- non-proprietary name (rINN or any common name)
- pharmaceutical formula (in details attachments)
- name and address of manufacturer of finished product
- commitment of health authorities signatory to the certificate to GMP periodic inspection
- statement specifying if the leaflet is the same in country, issuing the certificate, and the reason(s) if different
- date and number of registration of the product in the country issuing the CPP, and if this is not available then the reason
- name and address of health authority, issuing the certificate
- Summary of Product Characteristics (SPC). This should contain the following:-
- Proprietary name of the medicinal product
- Qualitative and quantitative composition of product stating the generic names of common flames of the active ingredient and important ingredient(s)
- pharmaceutical form
- Clinical particulars such as:-
- therapeutic indication(s)
- Posology and method of administration
- Special warnings and precautions
- interactions with other medicaments and other forms of interactions
- use during pregnancy and lactation
- Effects on ability, to drive and operate machinery
- Undesirable effects
- Pharmacological properties
- Pharmacodynamic properties
- Pharmacokinetic properties
- Preclinical Safer data
- Pharmaceutical particulars such as
- list of excipients
- shelf life
- Special precautions for storage
- Nature and content of containers
- Instructions for use/handling
- Manufacturing authorization holder
- Manufacturing authorization number
- Date of first authorization/renewed authorization
- Date of revision of the text
- Legal category
- A separate file for the quality control laboratory including the following:
- Method of analysis for finished product
- Certificate of analysis for finished product (physical, chemical, biological and microbiological)
- Finished Product Specifications
- Validation of analytical test methods
- Certificate of analysis of standards and specifications
- Safety measures
- Reference standards (sufficient quantity)
- Related substance reference standards (sufficient quantity)
- Full description of the active ingredient(s) and excipients including colouring agents, flavouring agents, presentations, emulsifiers, and other pharmaceutical means.
- Full description of vehicles and carriers of the product e.g., gelatin capsules, pessaries, rectal enemas etc.
- Method of manufacture of the finished product
- Names and addresses of any pharmaceutical manufacturing site involved if any step(s) of manufacturing of the finished product
- Products that are still protected by patent tights will not be registered if submitted by other than the holder of the patent rights
- Full description of the outer pack and all accessories included to give the proper dose such as syringes, pipettes etc.
- The concentration of the product should be clear and specific per unit mass or volume.
- Pharmacological studies including pharmadynamics and pharmacokinetic studies
- Toxicological studies (new products including newly introduced generics)
- Clinical studies (new products including newly introduced generics) (for well established generic products reference articles and documents are enough)
Source of starting material should be clarified.
The product label should carry the following information on external and internal pack in English/Arabic-
- Proprietary name followed by common name of active ingredient(s)
- Pharmaceutical form and strength
- Contents by common flame and quantities per dose
- Pack size by weight, volume, or number of doses.
- List of excipients with certain pharmaceutical function
- For injectables, eye drops, and external use products all excipients should be mentioned
- method of use
- expiry date by month & year
- Special storage requirements
- marketing authorization holder
- manufacturer of the finished products
- batch number
- In case of OTC drugs, clear method of use should be specified.
- In case of blisters, proprietary name, common name, marketing authorization holder, batch number and expiry date should be mentioned
- ln case of small containers such as ampoules the following should appear on the label (as minimum requirement)
- name of drug, strength, route of administration
- manufacturer name and/or logo
- method of use
- expiry date
- batch number
- contents by weight, volume or units
The product patient leaflet should contain the following in English/Arabic
- brand name followed by common name
- pharmaceutical form and concentration or strength
- qualitative and quantitative information about active ingredient(s) and excipients in common name
- pack size and contents by volume, weight or number of dosage
- pharmacotherapeuetic group in clear understandable language.
- MAH and manufactudnglicence holder
- therapeutic indication(s)
- contra indication(s)
- drug-drug interaction, food interaction, alcohol drug interaction and others.
- any special precautions
- use during pregnancy, lactation, elderly, children and other patient categories
- effect on driving and machinery operating
- probable allergy-producing addresses
- dose and dose regimens
- clear description of administration method
- antidote and treatment of overdose
- any information related to period of use, skipping or forgetting doses, abrupt withdrawal, best time of administration of doses, etc.
- side effects and advice on reporting any adverse reaction to doctors and pharmacists
- warning against use after expiry date on Pack
- number of leaflet and date of last revision
A full bioequivalence study report or equivalent, from an independent lab should be submitted whenever a generic product is submitted for registration. For registration of under-licence products for out-of-patent molecules a bioequivalence study comparing it with the parent product is required.
Products imported for government outlets and in large pack sizes should carry the full medical profession leaflet. In case this could not be met and patient leaflets ate supplied in the pack, extra medical profession leaflets should be submitted to the Ministry of Health for distribution upon request.
If the pharmaceutical product contains an animal product the source and kind of animal should be specified.
Only approved colouring substances, flavouring substances, diluents and additives should be used in the manufacturing process as approved by major drug regulatory agencies, WHO and other international organizations.
Price certificate authenticated by the health authorities in country of origin stating the following:-
- ex-factory price.
- wholesale price in country of origin
- public sale price in country of origin
- ClF price GCC countries
- suggested ClF price to Bahrain
- Stability studies should be attested by quality assurance section and authorized by manufacturer. Stability studies should be conducted on the product in the same container closure system intended for marketing in Bahrain.
- Stability studies should be provided for at least 3 production batches, the following should be clarified at the beginning of the document
- batch numbers, dates of expiry of batches tested
- Storage conditions of T & RH used during the study protocols
- temperature and relative humidity
- Samples should be taken for analysis at certain points of time i.e. every 3 months at least during the first year and every six months thereafter
- analysis method
- parameters tested
- conclusion of the studies pertinent to stability and suggested shelf-life and storage condition (the conclusion could be added at the end of the document)
- Tests should cover physical, chemical, biological and microbiological attributes.
- For accelerated stability studies, testing should be done at certain time points: initial, 3 and 6 months at least. If there is a change in the specifications, then testing should be done at intermediate conditions at four points of time: kiital, 6, 9 and 12 months (this includes initial and final readings)
- Real time should cover at least 12 months duration at long term and at least 6 months data at intermediate storage condition. For zones I and II, /long term conditions are 25ºC±2 ºC and 60%±5% RH. For Zones III and IV, long terms conditions are term conditions are 25ºC±2 ºC 60%±5% RH. Which is the same as the intermediate conditions
- Stability studies conditions: Long-term
The cancellation of a manufacturer's registration is done under any of the following conditions:
- If it has not submitted any of its products for registration within a year of the company registration.
- If forgery in its papers and documents has been proven.
- If it has violated the regulations and guidelines of GMP.
If after reconsideration of the representations, the Authority still rejects the application, the applicant may if not satisfied with the decision appeal to the Minister for Health. The appeal shall or English. However, where original certificates are in another language, copies shall be presented together with certified Kiswahili or English translations. These guidelines should be read together with the Tanzania Food, Drugs, and Cosmetic Act 2003 and regulations made there under.
Information required from Pharmaceutical companies for Registration