---
title: What Is an SmPC?
description:    SmPC stands for Summary of Product Characteristics. An SmPC is used by healthcare professionals - such as doctors, nurses, and pharmacists - and explains how to use and prescribe a medicine SmPCs a
---

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# What Is an SmPC?

 

![](https://support.datapharm.com/hubfs/image-png-Feb-09-2023-01-31-23-8195-PM.png)

SmPC stands for Summary of Product Characteristics. An 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. It is then checked and approved by the UK or European medicines licensing agency

 

SmPCs have to contain certain numbered headings and information. See below, in simple terms, what the headings mean and what each section contains

**Section 1. Name of the medicinal product**

The brand or trade name of the medicine

**Section 2. Qualitative and quantitative composition**

The names of the active ingredients in the medicine which make it work. How much active ingredient it contains. For example paracetamol 500mg

**Section 3. Pharmaceutical form**

The physical form of the medicine. For example a tablet, injection, ointment, or syrup

**Section 4. Clinical particulars**

How the medicine should be used or taken

> **Section 4.1 Therapeutic indications**
> 
> The diseases or medical conditions the medicine is approved to treat. Sometimes a healthcare professional might decide to use a medicine to treat conditions that are not listed on the SPC
> 
> If you are not sure why you have been given a medicine, please talk to your doctor or pharmacist

> **Section 4.2 Posology and method of administration**
> 
> Posology means dose. The dose, or dose range, that is used

> **Section 4.3 Contraindications**
> 
> The situations where a medicine should not be used or taken

> **Section 4.4 Special warnings and precautions for use**
> 
> Medicines always need to be taken or used carefully. This section tells the prescriber when to be especially careful when prescribing a medicine for certain people

> **Section 4.5 Interactions with other medicinal products and other forms of interaction**
> 
> Whether the medicine is known to react or interfere with any other medicines, herbal or dietary supplements

> **Section 4.6 Pregnancy and lactation**
> 
> Information about taking or using a medicine if you are pregnant, thinking of becoming pregnant, or breast-feeding a child.

> **Section 4.7 Effects on ability to drive and use machines**
> 
> The medicine's effect on your ability to drive or use machines

> **Section 4.8 Undesirable effects**
> 
> The side effects that people can get when they take or use the medicine. How often the side effect happens, how severe they might be, how long they might last for, and what you should do

> **Section 4.9 Overdose**
> 
> What could happen to you if you take or use too much of the medicine

**Section 5. Pharmacological properties**

How the medicine affects your body and what your body does to the medicine

> **Section 5.1 Pharmacodynamic properties**
> 
> How the medicine has an effect on the body

> **Section 5.2 Pharmacokinetic properties**
> 
> How the medicine gets into your body, how it gets to the part of the body where it needs to act, how the body changes the medicine, and then how the body removes it.

> **Section 5.3 Preclinical safety data**
> 
> Information about the tests that were carried out in a laboratory or on animals, before the medicine was used for humans. It includes the test results which are relevant to prescribers

**Section 6. Pharmaceutical properties**

Information about the ingredients in a medicine, the packaging, and how it should be stored.

> **Section 6.1 List of excipients**
> 
> Which other ingredients are in the medicine, apart from the active ingredient

> **Section 6.2 Incompatibilities**
> 
> This section, along with section 4.5, tells you if there are any other medicines that shouldn't be mixed or taken with this medicine

> **Section 6.3 Shelf life**
> 
> The maximum amount of time the medicine can be stored for

> **Section 6.4 Special precautions for storage**
> 
> How and where to store your medicine

> **Section 6.5 Nature and contents of container**
> 
> Information about the medicine's packaging

> **Section 6.6 Special precautions for disposal and other handling**
> 
> How to make-up or give the medicine and how to get rid of any left over medicine.

**Section 7. Marketing authorisation holder**

The Marketing Authorisation Holder (MAH) is the name of the pharmaceutical company who owns the licence to sell the medicine. Sometimes the Marketing Authorisation Holder allows a different pharmaceutical company to sell their medicine

**Section 8. Marketing authorisation number(s)**

When the regulatory authority approves a medicine, they give it a number - the marketing authorization number

**Section 9. Date of first authorisation/renewal of the authorisation**

The date of first authorisation is the date the regulatory authorities first approved the medicine. If the marketing authorisation has been suspended and then granted again, there may also be a renewal of the authorisation date

**Section 10. Date of revision of the text**

If an SmPC changes, this is the date the pharmaceutical company sent the changes to the regulatory authority for their approval

**Section 11. Dosimetry**

This section is only on SmPCs for radiopharmaceutical products. It tells you how much radiation you are exposed to

**Section 12. Instructions for preparation of radiopharmaceuticals**

This section is only on SmPCs for radiopharmaceutical products. It tells you how to get rid of any unused or waste products safely

**Legal category**

Every medicine has a legal category.

*POM (Prescription Only Medicine)* - you can only get the medicine on prescription 

*P (Pharmacy)* - you can only get the medicine from a retail pharmacy

*GSL (General Sales List)* - you can buy the medicine without a pharmacist, for example in a supermarket

*CE Mark* - used on devices

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