Glossary of MHRA terms - S

S

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SABS
See: CAS

SAMM
Safety Assessment of Marketed Medicines. SAMM guidelines apply to the conduct of all company sponsored studies designed to evaluate drug safety.

Scientific Steering Committee DG XXIV: Medicinal Products and Medicinal Devices
One of eight committees established by the Commission to provide them with independent scientific advice in the field of consumer health and food safety.

SCOP
See: PEAG.

SEAC
Spongiform Encephalopathy Advisory Committee

Section 4 Committee
These are committees established under the Medicines Act: to promote advice on the safety, quality or efficacy of medicines and to promote the collection and investigation of information concerning adverse drug reactions.

S 21(3) Letters
When an appeal under section 21(1) or S 28(3) of the Medicines Act is unsuccessful the Committee's advice is sent to the company. This offers the company further appeal rights to the Medicines Commission.

Section 44 letters
Letters issued under the 1968 Medicines Act to seek additional information. S 21(1) or S 28(3) LETTERS. This is the method by which provisional conclusions of the Committee on Safety of Medicines are conveyed to a company.

SERNIP
Safety and Efficacy Register of New Intervention Procedures. This body decides what level of expertise is necessary for a surgeon carrying out a new interventions procedure and whether the new procedure needs to be under a formal research programme.

SI
Statutory Instruments

SIGN
Scottish Intercollegiate Guidelines Network

SmPC
Alternative abbreviation for SPC.

SmPC fragments
SmPC fragments are the 27 individual sections or subsections that make up the full Summary of Product Characteristics (consisting of 1 to 3, 4.1 to 4.9, 5.1 to 5.3, 6.1 to 6.6, 7 to 12) covering topics such as the therapeutic indications, contra-indications and undesirable effects.

SPC
Summary of Product Characteristics or Special Precautions and Contra-indications or Supplementary Protection Certificate.

SPECT
Single photon emission computed tomography.

SSRIs
Selective Serotonin Reuptake Inhibitors.