Registration process has a very complex structure and each registration is different from others. It is possible that registration of the same range of products in the same country have slightly different requirements. Therefore, it is the BD Salesperson's core responsibility to check with each Customer in detail all the registration requirements while cross-checking it with the general requirements of the country to ensure higher success rate of a registration.
BD Salesperson can refer to the Countries database in the system here: Countries
Once a Prospect has confirmed that registration will be required for the product range that they intend to import, BD Salesperson can further clarify the following points:
Costs related to registration including but not limited to application, submission, sample testing, site inspection, etc. that are to be paid to the Country MOH will have to be borne by the Customer. On very rare occasions, registration fee refunds may be approved. However, this is mostly not applicable for new Customers.
Documents Origin means the country where the documents are coming from. Even though the country of origin is from China/India, some Customers may still assume that regulatory affairs are from the USA.
BD Salesperson needs to clarify to the Customer that although the company is American owned, the production for international markets is located in China/India origin of all the documents will also be India/China, not USA.
Some Customers might think that AdvaCare is the manufacturer and that all the documents will be coming under the AdvaCare name. BD Salesperson needs to make sure to the client that AdvaCare is partnered with different Joint Venture facilities and the documents will be from the name of Indian/Chinese Joint Venture facilities and not AdvaCare.
The most crucial part in the discussion of a registration will be the actual requirements for submission and completion of registration with the Country MOH. Ideally, BD Salesperson can ask for the official guideline of the registration requirements from the Customer. However, in many cases the Customer may have its own set of requirements that vary slightly from the actual guideline. Upon receiving the requirements, it is recommended that BD Salesperson summarize again all the requirements under one email and re-confirm if some aspects are really NOT required . The basic requirements for any registration includes:
Refer to this reference SOP for further information: Document Glossary
Most administrative documents can be provided by AdvaCare.
Quality certifications are most important to be accurate from the Customer, as it will determine the Vendors quoted by Purchasing Dept. For Pharmaceutical products in particular, some countries may require higher standard certifications which can be either SRA (Stringent Regulatory Authority approved certifications such as USFDA, EUGMP, TGA, etc.) or has passed that country MOH Inspection.
A dossier is a collection of papers or other sources, containing detailed information about a particular person or subject, usually compiled in a standardized format depending on each country's requirements. A dossier can be an entire folder of pertinent information regarding a product or subject. That means a variety of reports can make up the contents. It is a detailed project and takes time to complete as it involves reports of the product which are taken over years. The requirement of a dossier shows the higher level of commitment required in the project, and therefore must reflect in the registration deposit cost.
Separate technical parts that may make up a dossier. It may be required separately or without the requirement of a dossier. Generally can be provided by most Vendors or prepared by RA Dept.
Documents are authenticated (notarized or legalized) to deter fraud and to ensure proper execution. Many countries MOH require documents to be notarized and legalized for the registration procedure to make sure that the documents submitted are legal and not fake.
Some Country MOH might require samples to be submitted together with the documents for registration. The MOH may check and test the samples before registering a product. If samples are required, check which of the samples may be acceptable:
Some Country MOH may require that the manufacturing facility to be registered is Inspected by the MOH officials prior to approval. In some countries, this may no longer be required if proof of compliance under any SRA standards can be provided. Regardless, it may be easier to register a standard GMP facility without SRA certifications even if it means the requirement of inspection. In this case, BD Salesperson must confirm with the Prospect whether they are willing to process registration with site inspection, and if so if they are willing to cover the costs of inspection .
If site inspection cost is approved by the Prospect, ask for any guideline/schedule of how the standard site inspection will be carried out .
It is important that order commitments are discussed prior to starting a new registration. The following points are recommended to be confirmed with the client, and is mandatory to be asked if the inquiry involves RFQs for Indian Vendors and RFQs for SRA Certified Vendors :
As per AdvaCare policy, a registration deposit from the Customers is required in order to start a registration with a Prospect. Registration involves a lot of costs, time and efforts in dossier and sample preparation. Customers that do not agree to the deposit cannot proceed with registration due to the low guarantee of commitment to complete the process. After clarifying all requirements from Point No. 4, BD Salesperson can provide a rough estimate of what the amount of deposit may be like to avoid future misunderstanding with the Customer. Some costs related to Registration Deposit can be referred to here:
For accurate information of the amount of deposit, BD Salesperson has to confirm with Purchasing, Registration, Logistics and/or Design Dept. as applicable in the RFQ Task. On some occasions, registration deposit refunds may be presented to very promising Prospects. This will require order commitments and Prospect approval from the VP of Sales.
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