The person who is authorized to sign the NHRA-MVC Participation Agreement on behalf of the MAH and handle financial payment to NHRA-MVC for their Company.
The creation of a hierarchical, parent-child relationship between a containing object (i.e., parent) and one or more objects (i.e., children) that are contained. Aggregation requires unique identification (serialization) of the parent. In pharmaceutical supply chain practice, each aggregated child is uniquely serialized mainly because of regulatory requirements mandating serialization of registered trade items.
The field of two or more digits at the beginning of an element string that uniquely defines its format and meaning.
An element string that provides additional information about an entity identified with a GS1 identification key, such as batch number associated with a Global Trade Item Number (GTIN).
The batch or lot number associates an item with information the manufacturer considers relevant for traceability of the trade item. The data may refer to the trade item itself or to items contained in it.
A certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and the applicant for the certificate in the exporting country.
Employed by MAH to provide services on their behalf and will generate data that must be sent to the NHRA-MVC Traceability Hub by the MAH. CMO’s do not hold any rights, and therefore no responsibility concerning the product and will not directly report information to the NHRA-MVC Traceability Hub.
It is the country where the pharmaceutical product has been released with certificate of analysis signed by the responsible qualified person.
Different kinds of media that can hold GS1 Identification keys and application identifiers.
An expiration date or expiry date is a date after which a product should no longer be used, either by law or by exceeding the anticipated shelf life for perishable goods.
The GS1 Data Matrix barcode is a graphic representation of digital data in a two-dimensional format with high information-decoding capacity.
The GS1 Global Trade Item Number (GTIN) is an identification key that uniquely identifies products worldwide. It can be encoded in various types of data carriers, including GS1 Data Matrix.
The global location number (GLN) is a globally unique GS1 identification number that can identify any location in the supply chain that needs to be uniquely identified.
The company that will send the invoices for payment when products are shipped to Bahrain is known as the Invoicing Company (IC).
For more information: What is an Invoicing Company / How Do They Sign-Up for NHRA-MVC
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Manufacturing site of batch release, the final manufacturing site from which the medicine is dispatched to Bahrain.
The pharmaceutical company that legally holds the right and responsibility of marketing the medicine in Bahrain. The MAH will be responsible for sending data to the NHRA-MVC Traceability Hub on behalf of its manufacturing sites, Contract Manufacturing Organizations, Repackagers, and Third–Party Logistics companies. The MAH will contract with NHRA-MVC by way of the NHRA-MVC Participation Agreement. The MAH will be legally authorized to sign the agreement on behalf of its authorized manufacturing sites, Contract Manufacturing Organizations, Repackagers, and Third-Party Logistics companies.
An independent regulatory body established in 2010 under Law No. 38 of 2009. NHRA’s mission is to regulate the provision of healthcare in Bahrain and ensure appropriateness, continuity, efficiency and safety in delivering health services, both in the governmental and private sector. It will be based on the best scientific evidence and healthcare best practices, in accordance to international standards.
The package leaflet is the medicine information provided in the pack. It should be drawn up in accordance with the summary of the product characteristics.
Pharmaceutical Product regulation is the responsible department for medicine licensing at NHRA.
The first level of packaging for the product marked with an automatic identification and data carrier (AIDC) either on the packaging or on a label affixed to the packaging.
A level of packaging marked with an automatic identification and data carrier (AIDC) that may contain one or more primary packages or a group of primary packages containing a single item.
The serialization number (SN) is used to identify each product unit of product identified by GTIN. The SN used for a product cannot be used again for the same product. The SN can be up to 20 alphanumeric characters in length.
A logistics unit of any composition established for transport and/or storage, that needs to be managed through the supply chain. Logistics units take many forms (e.g., a single box containing a limited number of products, a pallet of multiple products or an intermodal container containing multiple pallets).
An electronic device to read barcode and convert them into electrical signals understandable by a computer device.
The definitive description of the product. The SmPC is an integral part of the marketing authorization and should take the form as outlined in Annexes
The person who will act as the Point of Contact (POC) for the technical onboarding of their company to the NHRA-MVC Traceability Hub.