These instructions are "for trial use" as we work on the first therapeutic area - anti-infective products. Please add comments about improving the work process in the comments section at the bottom of this page
Work process diagram
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In whichever tab/worksheet you choose to work in, please copy columns E, F G and G H and enter your country name into the first row.
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If you select D, please give your reason for not wishing to support the inclusion of the concept in the International Edition.
If there are any comments that you wish to make for discussion etc., please note these in the fourth column. For example, you may wish to note that the international edition does not usually support synonym concepts for medicinal product concepts, but for the particular concept under review you feel that a synonym would be justified.
If you have concepts in your local content that are in this therapeutic area and which are not in the International Edition and are not in this list, please make a note of them and provide them as a list of FSNs (and a local ID if possible) back to the Project group.
If you see that three or more countries have already supported inclusion of a concept (for example, the "Product containing only aciclovir and hydrocortisone (medicinal product" shown below in the Worked Example, supported by Norway as the originator of the spreadsheet and by Spain and the USA), then it is not necessary to add further references etc. and you are welcome to move on to other content elsewhere in the worksheet(s) which has not yet been analysed. This may mean that the worksheets become quite complex to manage; this is a first draft of the analysis and review process and the use of a GoogleSheet to implement it; we will discuss with the group and revise the process based on your feedback from working with this first therapeutic area.
Worked Example using the MP only tab/worksheet
In this example, Spain is the first county to work in the MP only tab/worksheet, so copies columns E, F, G and G H into columns H, I, J and JK.
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 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.
Please note that in the example diagrams below, the column H "Comments/points for further discussion" is not shown.
The USA is the second country to work in the MP only tab/worksheet, so the team there copy columns E, F, G and G H into columns KL, M, L N and M O and work in this area. If needed, they can "hide" columns E, F and G and H, I and J from Spain-K, especially if the worksheet is getting quite large.
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In their analysis, the American team also find that there is at least one product in their local data which would fulfil this MP only concept, and they too 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 K L and a reference to authorised product information for a real medicinal product that supports this. For time and resource reasons, they have not filled in row 4, even though the product they have selected to support the concept in row 3 also supports the concept in row 4.
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