There may be situations where an agreement is not necessary, for example. B if the wholesaler is not in a contractual relationship with the order for payment and is not considered a potential source of safety information and would therefore not be part of the pharmacovigilance system of the order. In addition, there must be a follow-up of companies that violate the agreements by sending late reports or by sending no reports at all. How to identify a company that is a remote site and does not send serious adverse events is another difficult topic and involves cooperation with the company`s quality and audit groups. As this Agreement is binding on all partners, the Legal Service should review and approve the document. Typically, companies are developing the SDEA model. Scope is the key to defining the conditions for the rest of the agreement. Within the scope, the products and territories covered by the VPA (and by which party) can be defined. However, it may be easier to have this detailed information in an appendix to the agreement if the products/areas covered are bulky and subject to frequent changes. Another area that could be included in the scope is to define the role of each party. An example could be the confirmation of the part of the MAH and which one is the distributor? Are the parties the two MAH, but in different areas? Or maybe the distributor is also the local MAH? This information helps the reader understand the requirements of each party.

Another point to be included in this section could be the language in which the information should be exchanged. This is an important point, as partner companies may have branches in countries that speak different languages. It is therefore necessary to choose a common language. Account should also be taken of the party transmitting the information to the regulatory authorities and the language applied by the regulatory authorities in an area. If a journalist does not remember the name of the drug he took when he experienced an adverse event, it would not be a valid case. This approach also applies to adverse events. If a patient claims to have experienced „symptoms“ but cannot be more specific, such a report can be considered technically valid, but it is of very limited value to the company`s pharmacovigilance department or to the drug supervisory authorities. [6] To obtain the necessary approval and market their finished forms of loan, these MA holders may have different business relationships with other pharmaceutical companies, CRS or other service providers. .

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