Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 6 months after the last prescription collected.

Provenance

This is a best practice recommendation.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 10 years after the death of the patient.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years from last entry.

Provenance

The Human Medicines Regulations 2012 (regulation 253 (5))

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 5 years.

Comment

Must keep all documents relating to the transaction. Specific requirements for what information must be included.

Provenance

The Veterinary Medicines Regulations 2009 (SI 2009/2297)

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years.

Comment

This also applies to any non-FP10 prescriptions for patients being treated under an NHS-commissioned care service.

Provenance

• Royal Pharmaceutical Society. Medicines, Ethics and Practice. Edition 42. July 2018.
• The Human Medicines Regulations 2012 (regulation 253 (5))

Unique record

No, there is likely to be more than one copy.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 5 years.

Comment

Should have the certificate of conformity including the following details:

• source of the product
• to whom, and the date on which the product was sold or supplied
• the prescriber’s details
• the quantity of each sale or supply
• the batch number of the product
• details of any adverse reactions to the product sold or supplied

The 6-tax-years limit relates to disputes over simple contract (Limitation Act 1980). Manufacturers, and sometimes others involved in a product’s supply chain, are liable for their products under the Consumer Protection Act 1987. Therefore, it is recommended to keep delivery notes or invoices for 11 years as product liability records.

Provenance

The Human Medicines Regulations 2012 (regulation 170)

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 5 years.

Provenance

Consumer liability legislation

Consumer Protection Act (CPA) 1987 allows patients to claim for injury due to a defective product (medicine) up to 10 years after a medicine has been administered.

Records of manufactured products (e.g. worksheets) can prove that the product was or was not defective. The prescription or other clinical records will only indicate that the patient was prescribed or dispensed an item, but will not give any indication how the product was made and what ingredients were used. If the problem is a contaminated ingredient, it is possible to partially pass the responsibility to the supplier of the defective ingredient.

Adult patients (18 years and over)

Keep manufacturing records for 11 years (10 years as part of CPA + 1 year best practice safety margin).

Paediatric patients

If a child suffers from unexpected serious adverse effects after taking a medicine, they’ve got:

• any time up to 3 years after their 18th birthday to sue in negligence (up until they’re 21 years)
• 10 years from taking the medicine to sue under CPA

RMCoP states that records relating to children should be kept until the child’s 25th birthday (26th birthday if 17 years old at time of treatment), unless there are other factors which indicate the record should be kept for longer.

Therefore, in line with RMCoP recommendation, keep all paediatric manufacturing records for 25 years.

See also The Human Medicines Regulations 2012 (regulation 170).

Unique record

No, there is likely to be more than one copy.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 5 years.

Comment

Should have the certificate of conformity including the following details:

• source of the product
• to whom, and the date on which the product was sold or supplied
• the prescriber’s details
• the quantity of each sale or supply
• the batch number of the product
• details of any adverse reactions to the product sold or supplied

The 6-tax-years limit relates to disputes over simple contract (Limitation Act 1980). Manufacturers, and sometimes others involved in a product’s supply chain, are liable for their products under the Consumer Protection Act 1987. Therefore, it is recommended to keep delivery notes or invoices for 11 years as product liability records.

Provenance

The Human Medicines Regulations 2012 (regulation 170)