RFQs for registration are the new RFQs for countries that require to complete registration of Vendors or products before starting an order.
This SOP will explain the process of how Purchasing Person needs to handle RFQs for Registration.
Getting started with Registration
Purchasing Manager will assign the new RFQs for Registration the same way as any other RFQ. When Salesperson creates a new RFQ task they will add the following information to the task description: "Existing Client" or "New Client", type of inquiry "Registration" or "No registration", and Registration Requirements. Purchasing Person needs to assess this information to know how to work with the RFQ.
If the registration RFQ is for existing client, Purchasing Person needs to note this and connect this RFQ with the other orders or registrations of the same client - it could help to understand the requirements or capabilities of the client, and to understand which factories to talk to for the new RFQ.
Registration is the process that is required by some countries MOH (Ministry of Health) before it allows to import products. Registration is typically required by some regulated and semi-regulated markets for healthcare products. Some countries don't allow import of healthcare products without prior registration at all, other countries require to issue import permit, and some countries don't require any documents at all. Registration guidelines are establish by every country MOH and usually can be found on MOH websites. Each range of healthcare products in every country has different requirements. For example, supplements registration requirements are different from pharmaceuticals registration requirements, different from veterinary products, different from medical devices requirements, etc. Pharmaceutical products registration requirements are always the most strict out of all other healthcare products. Pharmaceutical products registration usually takes a long time, from one to two years (or more), and unless specified otherwise, products cannot be imported to the country until registration is completed.
In addition to documents requirements, MOH of certain countries might require inspection to be conducted before any Vendor registration is approved and products of this Vendor are allowed to enter the market.
Inspection (if required) is arranged by the country MOH that sends specially trained people to go to China (or India, or any other country of origin) to check whether Vendor facility complies to importing country requirements, based on Good Manufacturing Practices established by the country MOH. If inspection fails, the products of this Vendor are not allowed to enter the importing country. If inspection is passed, MOH issues a GMP that states that Vendor production site conforms to the requirements. Such GMP is valid for a certain period of time (usually 5 years), and needs to be renewed before expiration. Renewal process requires some of documents submitted again, and inspection to be carried out again. Every inspection has a fee that must be covered either by the Vendor or Customer. AdvaCare usually does not cover inspection fees as they are quite high (anywhere between 5,000 USD and 20,000 USD, depending on the country). If inspection is required, every Vendor only has to pass it one time for the whole period of validity - if another Customer from the same country wants to import the products of the Vendor who already has this country GMP, it is not needed to pass the inspection again. In this case, only documents/samples will be required. So it is always better to find a Vendor who already passed the inspection and has a country GMP.
Developing countries inspections are always less strict than developed countries inspections, therefore documents like EUGMP will always override almost any other country inspection. If a Vendor has certificates like EUGMP/TGA (Australia GMP)/MHRA (UK GMP)/USFDA (US GMP) this Vendor will likely not need to pass any other country inspection and can get an approval after providing only the required documents/samples.
Samples are required by some countries MOH to see the products that will be imported and to conduct the necessary testing of the samples. It is important to provide the samples from the same facility that will be registered.
Registration packaging designs must be submitted to MOH together with the documents/samples. Packaging designs of all future orders must be the same as designs submitted for registration.
Exclusivity means that company has provided Sole distributorship to a particular client in a particular market for some products, and those products cannot be offered to any other client in the same market. Usually if Vendor is exclusive for some products in the country we are interested in, there is no way around it unless exclusivity agreement of the Vendor is expiring soon or they are not happy with their current business and are willing to find the way to work with other customers in the same country, or cancel their current exclusivity.
Registration process has a very complex structure and each registration is different from others. It has happened more than once that registration of the same range of products in the same country requires different documents so it is Salesperson’s core responsibility to check with each Customer in detail all the registration requirements.
If the products are already registered in the certain country with the certain Vendor, the orders after registration completion must be produced with the same Vendor. Due to this, it is very important to identify the right Vendor for registration to avoid re-registrations of the same products in future.
How to handle RFQs for Registration
Registration requirements is the most important information of any new RFQ that needs registration. Purchasing Person needs to follow the process below that explains how to work with registration requirements.
1. Read the requirements carefully. Are all the requirements absolutely clear? Do the names of documents make sense (can Purchasing Person understand the names of documents)?
Note: If anything is not clear at this stage, Purchasing Person must send a task to Salesperson to clarify any unclear point. There is no shame in asking a question to make sure the information is understood correctly, however this must be done on the same day as RFQ is assigned. Purchasing Person has to check the requirements first to make sure all the information is clear as it might take Salesperson several days to clarify the requirements with Customer. So if Purchasing Person doesnt check the requirements first and lets it sit for several days unattended, then Salesperson will take several days to reply the questions, the delay of starting to work on the RFQ will be significant.
2. Is inspection required? If it is, this limits down the choice of Vendors as it is always better to use the Vendor who is already approved by importing country MOH, or has high certificates such as EUGMP/TGA (Australia GMP)/MHRA (UK GMP)/USFDA (US GMP)/etc.
3. Check samples requirements. Samples are an important part of any registration requirements. If samples are required, Purchasing Person must make sure the following information is provided:
3.1 Is quantity of samples mentioned?
3.2 Are samples required in AdvaCare packaging or plain packaging can be accepted?
IMPORTANT: Generally BD Dept. will include the details about samples in Task description. However, if for some reason these details are not mentioned Purchasing Person must send a task to BD Dept. to clarify. Samples in AdvaCare packaging will be more difficult and expensive to make, and for some pharmaceutical products it is almost impossible - for example for blisters packaging as the blister printing MOQ is very high. Sometimes Customers can accept samples with all elements in AdvaCare design except blisters. Sometimes it is also possible to find samples of products that were produced before in the office. Another option is to add samples to any order starting production or already in production. It is imperative that Salesperson and Purchasing Person think outside of the box and try to find the solution for any complicated registration requirements.
4. After all the requirements for documents and samples are clear, Purchasing Person needs to identify the vendors who might be able to produce the products and fulfill registration requirements. To identify the vendors Purchasing Person needs to first use 'Check catalogs' functionality in PA which will show which Vendors have the required products in the catalogs.
5. If a specific country approval is required (country MOH requires an inspection carried out before registration can be completed), Purchasing Person needs to use Registration Module to help to identify the Vendor who already has the necessary approvals. There are 2 ways to check which Vendors have necessary approvals:
a. Go to Site Documents in Registration Module as described in Creating Vendor Documents SOP. Search by Country name to see all Vendors that have Site Documents related to the given Country.
b. Go to Country page from 'Opportunity Info' tab in the task, and check 'Site Documents' tab under Country page. Evaluate the list of all Vendors that have Site Documents related to the given Country.
6. Purchasing Person must use Registration Module as a help tool to identify the suitable Vendor but at the same time, Purchasing Person must double check the information provided by Registration Module, as it might be old or not accurate. For example, the approval might expire since it was added to ERP, or apply to a different range of products from the products required. For example, Peru approval can be for injections, while RFQ contains tablets. Purchasing Person must always double check the information with the Vendor before replying to Salesperson. In addition, Purchasing Person cannot expect that the Vendors listed in Registration Module are the only vendors that have required approvals, it is still possible that some Vendors are not included in the list because Purchasing Dept. or Registration Dept. did not have accurate and complete information about some Vendors.
7. In addition to Site Documents, Purchasing Person should check 'Export Vendors' tab under Country page. This tab contains information about all Vendors that export to a given country. It can be a good indication of which Vendors might have the country approval, or export to the given country with or without registration. 'Export Vendors' tab will always contain more Vendors than 'Site Documents', it might contain Vendors whose status in the given country is unclear to Purchasing and Registration Dept., they might have the necessary approval after double checking.
8. Prepare the required documents list for the Vendor.
8.1 Take out the documents between AdvaCare and Customer. Such documents need to be taken out from the list before sending it to the Vendor. Examples of such documents: LOA, Manufacturing agreement (unless it is 3-party agreement), POA. Even if these documents are required to be signed with the Vendor, it is not necessary to ask the Vendor at this stage as they are prepared by AdvaCare and Vendor can easily stamp them when the time comes.
8.2 Take out the comments related to notarization/legalization of documents. Notarization/legalization will be made by Registration Dept. and is not required from the Vendor.
9. Give the product list to every Vendor suggested by the System, or more Vendors if Purchasing Person knows that others might be able to produce products and fulfil the requirements. Keep in mind inspection requirement - if it is required Purchasing Person has to identify which Vendor already has the country GMP to avoid having to pass the inspection - if possible. Otherwise, other certificates might be acceptable (as mentioned in point #2).
10. At the same time as giving the product list Purchasing Person must send the list of requirements to every Vendor to check and inform which requirements they can/cannot meet.
11. After Vendor replies about the documents, Purchasing Person must assess the answers and make sure about every single document required. There are times when Vendors say 'yes' to all the documents without checking properly, or without clear understanding what the documents names mean. Purchasing Person must make sure that this situation does not happen, all the documents must be thoroughly checked by the Vendor.
Note: It is Purchasing Person's responsibility to double and triple confirm with the Vendor which documents can/cannot be provided. If Vendor gives inaccurate information at this stage, wrong manufacturer will be confirmed for registration. If later on it turns out that Vendor cannot provide all the documents required, it will lead to failed registration and a lot of wasted time. In addition, prices for products confirmed might be higher from other Vendors as Salesperson always choses lowest prices before providing quotation to the Customer. Therefore, information must be accurate from the beginning.
12. After prices are uploaded, Purchasing Person must send a very detailed task to Salesperson with every Vendor's reply on registration requirements. Every point of registration requirements must be replied based on the list from task description. Some of the documents that Vendors cannot provide can be prepared by AdvaCare in-house Registration Dept. or by various agents, so no Vendor should be totally discounted by Purchasing Person at this stage. Such documents include BE studies, dossiers, etc. - however if the documents need to be outsources to agents registration will have additional costs, so it is always better to get the documents from Vendors.
