Distributors and Own Label Suppliers
Distribution and Own Label Supply
Distribution sites are no longer required to be registered on a Market Authorisation (MA), and indeed should not be. That is unless they are undertaking an own label supply role. An own label supplier, is a company which supplies a medicinal product in it's own livery (artwork / branding). A common example would be a supermarket selling hayfever tablets which are manufactured and licenced by a different company, but the supermarket makes arrangements which the MA holder to package the product in their packaging.
Own Label Supplier Addition
Variation code B.II.b.1.z : National fee for a single MA £308
Assessment of artwork, frequently this is considered consequential to the addition of the own label supplier, but if the livery has not been previously assessed by the MHRA, or has not been recently assessed >5 years, then a separate PIQ (Patient Information Quality) application will likely be required. The own label supplier can save money by utilising the Market Authorisation Holders patient information leaflet, in these scenarios a copy of the PIL does not need to be included, a statement in the application form is acceptable.
Addition of product name, many OLS wish to include a product name of their own invention, this is acceptable and is considered consequential to the OLS addition, i.e. a grouping of variations or, additional fees are not required. The change codes for consequential changes should be included in the list of change codes on the form, but it must be clearly stated in the scope of the application form that the change is directly consequential. In the case of OLS addition and product name the codes B.II.b.1.z and A.2.b should be applied.
Own Label Supplier removal
Key Points
Distribution sites are no longer required to be registered on a Market Authorisation (MA), and indeed should not be. That is unless they are undertaking an own label supply role. An own label supplier, is a company which supplies a medicinal product in it's own livery (artwork / branding). A common example would be a supermarket selling hayfever tablets which are manufactured and licenced by a different company, but the supermarket makes arrangements which the MA holder to package the product in their packaging.
Own Label Supplier Addition
Variation code B.II.b.1.z : National fee for a single MA £308
Assessment of artwork, frequently this is considered consequential to the addition of the own label supplier, but if the livery has not been previously assessed by the MHRA, or has not been recently assessed >5 years, then a separate PIQ (Patient Information Quality) application will likely be required. The own label supplier can save money by utilising the Market Authorisation Holders patient information leaflet, in these scenarios a copy of the PIL does not need to be included, a statement in the application form is acceptable.
Addition of product name, many OLS wish to include a product name of their own invention, this is acceptable and is considered consequential to the OLS addition, i.e. a grouping of variations or, additional fees are not required. The change codes for consequential changes should be included in the list of change codes on the form, but it must be clearly stated in the scope of the application form that the change is directly consequential. In the case of OLS addition and product name the codes B.II.b.1.z and A.2.b should be applied.
Own Label Supplier removal
The removal of an own label
supplier/distributor, including the deletion of any associated product name is considered a single type IA, A.7.
Own Label Supplier change in address
Also a type IA change but this time under change code A.5.b, a revised WDA (wholesale dealers authorisation) should be provided.
WDA exemption:
(ii) Retailers selling authorised medicinal products directly to the public do not require a
WDA. This includes individual retail outlets and, in certain circumstances, retail
chains, which use centralised warehousing to coordinate the supply of medicinal
product stock to individual retail outlets within the chain.
Where the retail chain obtains the medicinal product stock for supply to the public
through its retail outlets, it does not require a WDA. In these circumstances the
supply of medicinal products from the supermarket chain’s warehouse to each retail
outlet is conducted within the company only and does not involve supply to any
party outside of this. As such, the warehousing entity is not considered to be
wholesaling and authorisation requirements are not applicable.
It is important to note that retail chains which use centralised warehousing but
operate as franchised retail outlets are not exempt from WDA requirements. The
exemption applies where the company’s legal entity, which includes the warehousing
operation, is registered as a retailer.
http://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0008-guide-to-wholesaling-and-brokering-of-medicinal-products-for-human-use-in-ireland-v3.pdf?sfvrsn=8
WDA exemption:
(ii) Retailers selling authorised medicinal products directly to the public do not require a
WDA. This includes individual retail outlets and, in certain circumstances, retail
chains, which use centralised warehousing to coordinate the supply of medicinal
product stock to individual retail outlets within the chain.
Where the retail chain obtains the medicinal product stock for supply to the public
through its retail outlets, it does not require a WDA. In these circumstances the
supply of medicinal products from the supermarket chain’s warehouse to each retail
outlet is conducted within the company only and does not involve supply to any
party outside of this. As such, the warehousing entity is not considered to be
wholesaling and authorisation requirements are not applicable.
It is important to note that retail chains which use centralised warehousing but
operate as franchised retail outlets are not exempt from WDA requirements. The
exemption applies where the company’s legal entity, which includes the warehousing
operation, is registered as a retailer.
http://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0008-guide-to-wholesaling-and-brokering-of-medicinal-products-for-human-use-in-ireland-v3.pdf?sfvrsn=8
Key Points
- The addition/removal of OLS is a purely national submission regardless of the type of MA to which the change is applied e.g. National, DCP, MR.
- A change to the trading style of an own label supplier is also handled under the B.II.b.1.z change code.
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ReplyDeleteVery nice explaination. Could you please tell me which specific sections of the dossier will be changed to add an own bran supplier? Would SmPC be changed to add the new name of the product?
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ReplyDeleteIn conclusion, this blog post sheds light on the dynamic relationship between distributors and own label suppliers of medicinal products. The collaboration between these entities is instrumental in ensuring a robust and efficient pharmacy wholesalers uk. By fostering strong partnerships, prioritizing quality control, and staying responsive to market demands, distributors and own label suppliers can collectively contribute to the safe and effective delivery of essential medications to patients worldwide. Thank you for sharing this insightful article!