What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)
Well, COPP (Certificate of Pharmaceutical Products) is a certification for pharma medicines. It is a WHO-recommended certificate and the guidelines are made as per WHO standards. This is followed in the worldwide. It has its own importance. It is mandatory to submit it to the importing country when the product is designed for licensing authorization or renewal of registration.
This certification is very essential for a pharma franchise company. This helps to gain popularity and trust of the market. As people becoming aware and before purchasing medicines they do research about the company products and its market image. A WHO certified company can sustain in the market and can earn well.
There is a process for the COPP application. Proper documentation, rules are guidelines have to follow. Here in our next segment, we will discuss the procedure for the application process.
What is the Scope of COPP
The COPP is needed when the product tends that it is intended for registration or its renewal (licensing, authorization or prolongation) by the importing country, with the scope that the product is distributed or commercialized in that country. A Certificate has been suggested so that it helps the diminutive drug regulatory authorities (DRA) or also without proper quality assurance (QA) facilities in importing countries by WHO and also, it can evaluate the pharmaceutical products quality as per the condition of importation or registration. A CoPP, which recommends WHO to national administration for it's esurient that the confirmed method is analytical by the national laboratory, to view and also necessary to adapt the information of the product as per labeling requirements also bioequivalence and also some stability data. Regulatory practices vary in importing countries.Types of Medicines which COPP Issue
· Homeopathic Medicines· OTC products
· Active pharmaceutical ingredients
· Approved drugs
How to obtain CoPP?
To obtain a CoPP, a request is made to the exporting country’s health authority by the Marketing Authorization Holder (MAH). An authorized person issues the CoPP and returns it to the MAH. Also, other documents required to obtain a CoPP including an application for Export Certificate form, evidence of a GMP certificate (if applicable), Manufacturing License and the last approved SPC(Summary of Product CharacteristicsWho can apply for COPP?
An application for export certification must be submitted by the person/company who exports the drug. The certification is intended for a drug which meets the applicable requirements of the An act or Food Drug and Cosmetic Act 80COPP Application Process
· As per the requirement, the application for COPP has to be made to zonal or sub-zonal officer. Once the authorities execute an inspection and give satisfactory clearance, they issue the certificate on behalf of Drug Controller General India.· The application has to be addressed to DDC or ADC of the zonal or sub-zonal officer. A covering letter and product summary should be submitted along with the letter.
· Your application should have a clear message. The inspection process will happen accordingly. The CDSCP officer checks the application and accepts it if it seems ok for him.
· Along with the transmit letter, you should submit the list of products, product manufacturing license, product summary sheet, and site master file.
· You need to submit the list of your employees with their qualification, designation, and experience and other such details like equipment, utilities, and instruments are required.
· Submit the quality manuals along with specifications, master validation plan, and manufacturing layout with the application.
Process Time
Usually, it takes 20 government working days for completing an accurate COPP application.COPP free Structure
· First certificate:- 11025/-· Second Certificate:- 5670/-
· Third Certificate:- 2520/-
This is the whole procedure of it. It will definitely help to gain more information for it.
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