Archived CPM Technical Corrections

R_ProductListed (POCP_RM010100UV)

Completed Items

1. There are a number of Marketing Authorization Dates: First Authorization Date, Renewal Date, Variation Date, Withdrawal Date, Expiry Date. This can be solved by providing a recursive COMP relationship from an authorization to itself.

   DONE Gunther 16:33, 17 November 2010 (UTC)

2. Each Marketing Authorization produces a GTIN. Provide a SubjectOf shadow from IdentifiedEntity.

   DONE Gunther 16:33, 17 November 2010 (UTC)

3. IdentifiedEntity needs an effectiveTime

   DONE Gunther 16:33, 17 November 2010 (UTC)

4. SubjectOf needs a time to indicate when the relevant product information took effect

   QUESTION: such time range would be provided by the connected Act, wouldn't it?

   DONE: My thought was that the effectiveTime of the document could be different from the time when it was attached to the product. But now that I look at it, I don't think that distinction makes sense. --Jduteau 23:06, 18 November 2010 (UTC)

5. We need to indicate the dose form and the product classification that the marketing authorization pertains to.

   QUESTION: that is already supported because the Approval is connected to a Role whose player Entity has a dose form and can have classifications. Gunther 00:51, 18 November 2010 (UTC)

   CLARIFICATION: the authorization pertains to a specific form and classification. I'm unsure which Role you are referring to as the one with ProductEstablishment doesn't let me detail this.

   DONE: Relates to a specific product with form, etc. all part of the product description. Now, if you say the authorization relates to a "classification" then I think you really mean "indication", or "purpose" for which the product is approved. Currently this is held together by the product document, the label, that is approved. I have added the subjectOf participation to the specializedKind role. Gunther 14:09, 29 November 2010 (UTC)

6. We need to have the address of the governing agency address.

   DONE Gunther 00:51, 18 November 2010 (UTC)

7. How to tie the Marketing Authorization Procedure to the marketing authorization.

   ANSWER: the procedure may be reflected in the Approval.code, as it is in the U.S. or you might use the new Approval components to represent these procedures and other smaller actions.

8. How do we indicate the point and country where a measurement was made.

   ANSWER: ingredient strength is connected to a product and if the strength is different, then it is a different product. The country-specificity can be done with the Approval act.

   CLARIFICATION: In the US there is an inhaler that is measured by dose that reaches the mouth whereas in Europe exactly the same product is measured at the point the dose leaves the spray. The values are simiilar but different so there effectivly 2 different strengths which are equivalent if you use common measurement measures. Hence a need to express measurement point and countrry. After rethinking this, I believe that I can map this as a characteristic of the ingredient.

   DONE: I agree with you, these fine details can be done with those characteristics. Gunther 14:09, 29 November 2010 (UTC)