Pharmacovigilance Guidelines

2. Scope

These guidelines encompass monitoring, research, recording, archival and evaluation activities which are conducted to ensure the safety of licensed/approved medicinal products for human use, content and method of required emergency and periodic reporting and minimum requirements for registration holders to continue their pharmacovigilance activities.

1. Legal Basis

These guidelines have taken as its basis article 22 of "Regulation Regarding the Safety Monitoring and Evaluation of Medicinal Products for Human Use", published on March 22, 2005 in Official Gazette no. 25763 and drafted to be implemented with the abovementioned Regulation.

2. Definitions

Definitions of terms mentioned in these guidelines have been alphabetically listed as follows:

Adverse reaction / Adverse drug reaction

Refers to a harmful and unintended effect that emerges during approved normal dose usage of a medicinal product for human use in order to protect from a disease, to diagnose or treat a disease or to improve, correct or modify a physiological function.

Within this framework, an adverse reaction is considered synonymous with a suspected adverse drug reaction.

Unlike an event, an effect is defined when a causal relationship between the drug and the occurrence is suspected, in other words, it is defined when a healthcare professional reporting or investigating the occurrence evaluates it as a possibility. Unless the reporter has specifically indicated a negative provision with regarding to the causal relationship, an effect reported as spontaneous generally indicates a positive provision by the reporter.

Adverse event (adverse experience)

Refers to an experience which arises subsequent to the implementation of a medicinal product. It is not necessary to establish a causal relationship between the undesired circumstance and the treatment.

Minimum criteria for reportability

In order to approve an adverse drug reaction t as "reportable", the following minimum information must be provided:

(a) A healthcare professional with a verifiable identity who is conducting the report

The reporting individual's identity must be verifiable through his/her:

i) First and last names

or

ii) First and last name initials

or

iii) Address

and

iv) Profession (physician, dentist, pharmacist, nurse).

(b) A patient with a verifiable identity

The patient's identity must be verifiable through his/her:

i) First and last name initials

or

ii) Registration number

or

iii) Date of birth (if date of birth is not available, age)

or

iv) Gender. The data must be as thorough as possible.

(c) At least one suspected substance / medicinal product

(d) At least one suspected adverse reaction.

Minimum data refers to the minimum amount of information that is required for the presentation of a report. Subsequently, necessary efforts must be made to gather and present detailed information as it becomes available.

Upon receiving information directly from a patient (or from a relative) claiming the possibility that a serious adverse reaction may have occurred, the registration holder must try to obtain pertinent information from a healthcare professional involved in the care of the patient. Upon gathering this data, the occurrence may be accepted as reportable. When a patient reports an adverse reaction and presents medical documents, if the documents meet the minimum data requirement and verify the patient's report, this should be considered sufficient to approve the effect as reportable.

European Union Registration Date (EURD)

Refers to the date that the first registration for a medicinal product was granted in the European Union (EU) to the registration holder.

(EURD is the date that a registration was granted by the European Commission for a medicinal product which was registration within the scope of central procedures in the EU. For medicinal products which were licensed as part of mutually accepted procedures, the reference is the date when registration was granted by the member country.)