Getting Started with Registration

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Registration is the process that is required by some countries’ MOH (Ministry of Health) before it allows importation, marketing, or distribution of pharmaceutical/medical products in the country.

Registration guidelines are established by each 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.

There are three different internal classifications made for the countries, based on the regulatory strictness of each country:

• Unregulated - few documents are required to acquire import permission of a product.
• Semi-Regulated - registration is required for the products that are intended to be imported. The registration process usually involves submission of Administrative Documents, Quality Certifications, Technical Documents and even Product Samples. The MOH will review these documents and determine whether the product is considered up to standard to be marketed in the country.
• Regulated - similar with semi-regulated countries, however other than just document and sample submission, it may require either:
• Inspection of the manufacturing site by the MOH
• SRA (Stringent Regulatory Authority) certified: passed inspection from a list of countries (Reference Countries) with stricter regulatory requirements than the MOH Country. Some examples of SRA certificates include: US FDA, EU GMP, UK MHRA, Australia TGA, etc.

In any registration, some or all of the following will be required:

Registration Documents: that may include certificates, administrative or technical documents. For detailed information on most common documents required for registrations refer to the Registration Documents Glossary .

Document Authentication: Authentication of documents refers to the process of processing a document through a Notary (notarization), Embassy (legalization), or other public official (such as Apostille) to assess and verify the authenticity of a document by providing a seal.

Samples: product samples of the items that are registered for import, to be reviewed and possibly tested by the MOH.

Packaging Artwork Designs: the artwork of how the finished product packaging will look like. It is submitted to the MOH together with the documents/samples to ensure compliance of the product appearance in the market as well.

Exclusivity: while exclusivity usually refers to an agreement between Buyer and Seller, some MOH makes it a requirement that once a registration is completed, the Seller no longer has the right to register the same product with a different Buyer. Registration in countries that have exclusivity requirements must be pre-approved by BD Manager.

Inspection: site visit arranged by the country MOH by sending a specialized team 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 documents to be submitted again, and inspection to be carried out again. Every inspection has a fee that must be covered either by the Vendor or Customer. Inspection fees are normally 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.

More information regarding the regulatory requirements of each country can be found under the Registration Module - Countries .

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