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|How to Obtain a Certificate for Pharmaceutical Products in Kenya by Kenyans247(m): Wed Jan 2020 02:22pm|
The ministry of healthy in Kenya in collaboration with Ministry of Health enforces the Certificate of a pharmaceutical products CPPs to promote successful dialogue between the international pharmaceutical industry and Ministries of Health Kenya.
Please always refer to the guidelines for full instructions on how to complete this form and information on the implementation of the CPP Scheme.
These are the stages involved in applying for a certificate for Pharmaceutical products.
Step 1 - A printed Application form on the head paper of the Firm.
The applicant is required to submits a form which is generated by a computer (hard copy) application for a certificate of Pharmaceutical products. For purposes of complying with the WHO scheme, the applicant is classified as one of the following:
iii) Neither (Distributor
a) This certificate must conforms to the format recommended by the World Health Organization.
b) They should always be submitted as hard copy, with responses printed in type rather than handwritten.
c) Additional sheets should be appended, as necessary, to accommodate remarks and explanations as the case may be.
Step 2 - Attach the required Documentation on the application.
Attach the necessary documents issued by the competent Health Authority in the country of manufacture (the exporting country). These documents differ in some aspect depending on the Drug product you want to register.
The following details of the finished medicinal product are usually presented in the Certificate for Pharmaceutical Products:
i). name and dosage form of product
ii). name and amount of active ingredient(s) per unit dose (International Non-proprietary Name(s)),
iii). name and address of product license holder and/or manufacturing facility,
iv). formula (complete composition including all recipients; also particularly when no product license exists or when the formulation differs from that of the licensed product).
v). product information for health professionals and for the public (patient information leaflets) as approved in the exporting country,
vi) Some of the documents include contract manufacturing Agreement;
vii) Manufacturing license and free sale certificate,
Viii) Trademark registration,certificate of incorporation/business name and many more.
ix) A CPP Legalization perspective from the Exporting country is always required in Kenya.
All the necessary documents must be found satisfactory before any other process can be carried out. To obtain a certificate,the applicant must provide all required information. An application with incomplete information,or improperly mounted labels, will be returned to the submitter immediately.
Step 3- Evidence to manufacture the drug products.
There must be evidence that the Drug products is manufactured according to Good Manufacturing Practice (GMP). in the case of imported drug products (from foreign country),The importer must submit evidence that they are licensed to manufacture the drug products for sale in the country of origin.
You can go a head to Specify whether the person responsible for placing the product on the market is a:
i) manufactures (the dosage form);
ii) packages and/or labels a dosage form manufactured by an independent company; or
iii) is involved in none of the above.
Details of quantitative composition must be mentioned in the agreement as preferred by the regulation but their provision is subject to the agreement of the product-license holder.
Certification Scheme are described as providing information on the Quality/,Safety and Efficacy (QSE) of imported finished medicinal products, the appropriate use and in a reliable system of licensing an independently controlled quality control according to accepted norms
In this circumstance, permission for issuing the certificate is required from the product-license holder. This permission has to be provided to the authority by the applicant.
when foreign contractors are involved in the manufacture of the product. In these circumstances the applicant should supply the certifying authority with information to identify the contracting parties responsible for each stage of manufacture of the finished dosage form, and the extent and nature of any controls exercised over each of these parties.
Step 4- Permission from Health Authority to sale drugs
There must be evidence by the competent Health Authority, that the sale of the drug products does not constitute a contravention of the Drug laws of that country. i.e.Certificate of Pharmaceutical Product (COPP) that conforms to WHO format.The documents in respect of C1-3 shall be authenticated by the Kenyan Mission in that country. In countries where the
All Drug manufacturers companies both local and international in Kenya are Eligible for this certificate
i) The manufacture medicinal products should be fit for their intended use.
ii) The facility must maintain a clean and hygienic manufacturing area.
iii) cross contamination of drug product must be minimized from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
iv) All critical processes are validated to ensure consistency and compliance with specifications.
v) Changes that have an impact on the quality of the drug should be validated as necessary.
vi) Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
vii) Operators are trained to carry out and document procedures.
viii) Deviations are investigated and documented as required.
ix) Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
x) The distribution of the drugs minimizes any risk to their quality.
xi) A system is available for recalling any batch of drug from sale or supply.
xii) Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
a The certificate Number
b) Exporting (certifying country):
c) Importing (requesting country):
d) Name and dosage form of the product:
e) Active ingredient(s)2 and amount(s) per unit dose:
f) The applicant should provide information on the manufacture of drugs in their finished dosage forms.
g) measures to to assure the safety of workers.
h) The data on quality or efficacy
i) Quality Risk Management control measures
j) the required number of personnel with the necessary qualifications and practical experience.
k) The necessary authority to carry out the responsibilities.
l) The required practical experience in the manufacture and quality assurance of pharmaceutical products.
m) Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
n) Current Superintendent Pharmacists license to practice issued by the Kenyan Pharmaceutical and poison Board.
o) Premises Registration License from Kenyan Pharmacists and poison Board.
p) Certificate of Registration of brand name with trademark registry in the Ministry of Finance here in Kenya
q) Letter of invitation from manufacturer to inspect factory abroad, stating full name and location of plant.
s) The applicable fee payable only if documents are confirmed to be satisfactory. Nutriceuticals, medical devices and other regulated drug products have similar requirements, with minor variations. Specific details can be obtained from PPB.
Need for the Document
The Certificate of a Pharmaceutical Product is a certificate which is presenting several details on a registered finished medicinal product.
The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
it is issued in the format recommended by the Ministry of Health Kenya in Collaboration with World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.
Licensed pharmaceutical products (complying with the requirements of the marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing license) whose activities are regularly inspected by competent Kenyan authorities.
The content of CPP consists of the following main data
i) Exporting (certifying) country
ii) Importing (requesting) country
iii) Name, dosage (pharmaceutical) form and composition of the product [active ingredient(s) and amount(s) per unit dose]
iv) Information on registration (licensing) and marketing (presence on the market) status of the product in the exporting country
v) Number of product licence (including licence holder details, licence holders involvement in manufacturing if any) and date of issue, if applicable
vi) Appended summary of technical basis on which the product has been licensed (if required by the issuing authority)
vii) Appended current product information
viii) Details on the applicant for the CPP
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