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Project participants are invited to work with a choice from
- MP only concepts - on the first tab/worksheet (and MPF only are also present)MPF only concepts - on the second first tab/worksheetworksheet
- CD concepts - on the third second tab/worksheet
Please choose which worksheet to work with based on what you have in your own local systems and what you have time/availability for, but PLEASE NOTE that for MP only and MPF only concepts, a reference to authorised product information, such as a Summary of Product Characteristics (SmPC) or Product Label is required and that will most likely describe one or more real clinical drugs.
In whichever tab/worksheet you choose to work in, please copy columns E, F and G (or if you are the first participant, take those columns)and enter your country name into the first row.
Then for each row, please note which of the four decision categories you wish to give to that concept (note that the decision categories are also given on the fourth tab/worksheet, labelled as "Tables")
| Decision category | Explanation | |
|---|---|---|
| A | Have this CD/MP only/MPF only in national extension or MPD; support its inclusion in the international edition | |
| B | Have a concept very similar to this CD/MP only/MPF only in national extension or MPD; support its inclusion in the international edition but needs further discussion to finalise exact concept | |
| C | Do not have this CD/MP only/MPF only in national extension but do support its inclusion in the international edition | |
| D | Do not support inclusion of this CD/MP only/MPF only in the international edition |
For A or B, please provide a reference to authorised product information. If you select B, please describe the difference and any comments you may have about this (for example, that your local choice of reference strength substance is different from the concept as described in the FSN in column B)
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In this example, Spain is the first county to work in the MP only tab/worksheet, so takes copies columns E, F and G into columns H, I and J.
In their analysis, the Spanish team find that there is at least one product in the Spanish local data which would fulfil this MP only concept, and therefore they decide that they do support the inclusion of an MP only for "Product containing only aciclovir and hydrocortisone (medicinal product)" in the International Edition. So they put "A" in column E H and a reference to authorised product information for a real medicinal product that supports this.
The product that they have selected is a cutaneous cream, so it also supports the MPF only concept, so they can support the inclusion of this too and copy the same information into row 4. Note that this is optional; participants working with MP only concepts are not obliged to fill in the corresponding MPF only row(s) on this sheet or on the MPF only sheet.
The USA is the second country to work in the MP only tab/worksheet, so the team there copy columns E, F and G into columns H,I and J and work in this area. If needed, they can "hide" columns E, F and G from Spain, especially if the worksheet is getting quite large.
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