Julphar’s Goals

  • Incessant monitoring of the safety of Julphar products;
  • Assessing the risks and benefits of Julphar products;
  • Providing information to users on safe and effective use of products;
  • Identification, quantification and improving understanding of previously unknown adverse drug reactions;
  • Identification of patients at particular risk of having an ADR;
  • Monitoring the impact of any action taken.

All suspected adverse reactions will be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e. not consistent with product information or labeling; or
  • Serious, whether expected or not; or
  • Reactions to recently marketed drugs / medical products (being on the market for less than five years), regardless of their nature or severity.

Spontaneous reports of adverse reactions received from HCP will be reported by Julphar if:

  • The HCP has made a statement that a causal relationship between the event and the medicinal product is considered to be at least a reasonable possibility; or if
  • The HCP has not made any statement of the suspected causal relationship or has stated that the causal relationship is unknown; or if
  • Julphar considers that a causal relationship is at lease a reasonable possibility.

If the HCP has made an explicit statement that a causal relationship between the medicinal product and reaction has been excluded and Julphar agrees with this, the event will not be reported.

If Julphar is aware that a HCP has reported a reaction to one of its products directly to the authority, Julphar will still report the reaction, informing the authority that the report is likely to be a duplicate of a previous report. In this situation Julphar will provide all the available details including any registration number provided to the reporting HCP by the authority in order to aid identification of the duplicate.

Julphar will validate and follow-up all serious reactions reported by the HCP to the authorities. All available clinical information relevant to the evaluation of the reaction will be provided. Minimum information required will be included in the report (form attached):

  • An identifiable HCP reporter, the reporter will be identified by name or initials, address or qualification. Contact details for a HCP will be available;
  • An identifiable patient, the patient will be identified by initials, patient number, date of birth, age, age group or sex. The information will be as complete as possible;
  • At least one suspected active substance/medicinal product;
  • At least one suspected adverse reaction.