Table of Contents
What is the difference between Pi and SmPC?
The SmPC is part of the wider Product Information (PI), which also includes the Package Leaflet (PL) and names the authorization holder, as well as the conditions of the authorization. The equivalent of the SmPC in the United States is the United States Prescribing Information (USPI).
What is SmPC regulatory?
The Summary of Product Characteristics (SmPC) is an obligatory document concerning a medicine required (among other things) for the authorization of a medicinal product. The purpose of the SmPC is to provide product information to healthcare professionals.
Is SmPC same as package insert?
In the United States, the Food and Drug Administration (FDA) uses the United States Package Insert (USPI), while in the European Union, the European Medicines Agency (EMA) uses the Summary of Product Characteristics (SmPC) for product labels.
What is SmPC in pharmacovigilance?
A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC.
How do I reference SmPC?
URL: https://www.medicines.org.uk/emc/product/5692/smpc [6 January 2020]. Include the following in your reference: Author(s) in the format Surname, Initials. Title of review.
Why is SmPC important?
It is also used to prepare information addressed to patients. The SmPC is therefore a key document contribute to public health through provision of information on the benefits and the risks of a medicinal product.
What is E2B R2 and R3?
The structure of E2B (R3) compliant safety systems is different to the earlier E2B (R2) compliant systems. E2B (R3) presents new fields, removed and/or modified fields, and some data elements which have been moved from the case level to the event level.
How do I find EU SmPC?
The SmPC information can be found through the following sources: Websites of Health Authorities; such as the European Medicines Agency (EMA)…Structure of an SmPC
- Name of the product.
- Composition.
- Pharmaceutical Form.
- Clinical particulars – Includes therapeutic indications, recommendation for dosages and safety information.
What does a pharmacy data sheet contain?
A publication containing detailed prescribing information on a specific medicine. Pharmaceutical companies are required to prepare data sheets for all prescription medicines and restricted (prescription/pharmacy only) medicines in accordance with the legal requirements and regulatory guidelines of the local market.
Is package insert the same as prescribing information?
Package inserts (also known as Prescribing Information) are available for all prescription medications approved by the FDA. Similar information is available for nonprescription medicines and for some herbal medicines and dietary supplements as well.
Where can I find SmPC?
SmPCs are available online at: MHRA – information is arranged in an A-Z list by active substance, or you can use the free text search box. The online versions of SmPCs are updated on a regular basis, therefore contains the most up-to-date information.
What is null flavors in pharmacovigilance?
In HL7 v3, a flavor of null, or nullFlavor, describes the reason for missing data. For example, if a patient arrives at an Emergency Department unconscious and with no identification, a null flavor is used to represent the lack of information.
Does FDA accept E2B R3?
Please note, FDA is not currently accepting the submission of premarket ICSRs in the E2B(R3) format.
Where can I get SmPC?
The SmPC information can be found through the following sources:
- Websites of Health Authorities; such as the European Medicines Agency (EMA)
- Medicine dictionaries.
Who uses a SmPC?
The SmPC is used by healthcare professionals, such as doctors, nurses and pharmacists, and explains how to use and prescribe a medicine. SmPCs are written and updated by pharmaceutical companies and are based on their research and product knowledge.
What information can I find on the MHRA products website?
The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product’s properties and how it can be used Scientific reports about marketing authorisations for medicines
When does the new MHRA guidance come into effect?
Guidance for industry and organisations to follow from 1 January 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator. The below guidance should be followed from 1 January 2021.
How to submit summary of product characteristic fragments (SPC) to MHRA?
If relevant, the summary of product characteristic fragments (SPC) should be submitted to MHRA in the correct format using the templates below. If you do not use these templates your submission will be rejected. These templates should not be altered in any way, other than inserting the relevant information.
What is a type II change in MHRA?
Major variations (type II) MHRA needs to approve major variations before they are made. One example of a major change is adding a new therapeutic indication to a product or updating the current indication (the medical needs the product is used for). See the CMDh variations procedure guidance for the details of this type of change.