Record-keeping requirements
The MHRA places specific record-keeping requirements on persons who sell or supply a Special; this includes not only a Specials manufacturer or importer, but also doctors, pharmacists and dentists.
The regulations state that any person selling or supplying a Special must:
1) Keep the following records for five years:
- The source of the product.
- The person to whom the product was sold or supplied.
- The date on which it was sold or supplied.
- The quantity of each sale or supply.
- The batch number of the product.
- Details of any adverse reactions to the product they are aware of.
2) Make available these records for inspection by the Licensing Authority (MHRA).
3) Report serious suspected adverse drug reactions to the MHRA (healthcare professionals should use the Yellow Card scheme).