Immunization Regulations

t PUBLIC HEALTH ACT IMMUNIZATION REGULATIONS PLEASE NOTE This document, prepared by the Legislative Counsel Office, is an office consolidation of this regulation, current to April 11, 2026. It is intended for information and reference purposes only. This document is not the official version of these regulations. The regulations and the amendments printed in the Royal Gazette should be consulted on the Prince Edward Island Government web site to determine the authoritative text of these regulations. For more information concerning the history of these regulations, please see the Table of Regulations on the Prince Edward Island Government web site (www.princeedwardisland.ca). If you find any errors or omissions in this consolidation, please contact: Legislative Counsel Office Tel: (902) 368-4292 Email: legislation@gov.pe.ca Immunization Regulations Section 1 PUBLIC HEALTH ACT CHAPTER P-30.1 IMMUNIZATION REGULATIONS Pursuant to section 72 of the Public Health Act R.S.P.E.I. 1988, Cap. P- 30.1, Council made the following regulations: 1. Definitions In these regulations, (a) “authorized user” means (i) the Minister, (ii) the Chief Public Health Officer, (iii) the Deputy Chief Public Health Officer, or (iv) a person who has authorized access to the immunization registry pursuant to section 6; (b) “immunization registry” means the registry established pursuant to subsection 5(1); (c) “immunize” means to administer an immunizing agent; (d) “immunizing agent” means a vaccine, an immune globulin, or preventative monoclonal antibodies; (e) “member of a regulated health profession” means a member of a regulated health profession under the Regulated Health Professions Act R.S.P.E.I. 1988, Cap. R-10.1. (EC529/14; 520/17; 926/22, 420/26) 2. Vaccination reports (1) A member of a regulated health profession who immunizes a patient shall report to the Chief Public Health Officer, and to the Minister for inclusion in the PEI EHR established under the Health Information Act R.S.P.E.I. 1988, Cap. H-1.41, the following information in respect of each vaccination: (a) the patient’s name, date of birth, sex, address and provincial health number; (b) the name or drug identification number of the immunizing agent; (c) the date of immunization; (d) the name and location of the clinic or other place where the patient was immunized. Idem, influenza vaccinations (1.1) Revoked by EC346/18. c t Current to: April 11, 2026 Page 3 Section 3 Immunization Regulations Method and timing of reports (2) The information specified in subsection (1) shall be reported (a) to the Chief Public Health Officer (i) in an electronic form acceptable to the Chief Public Health Officer, or (ii) in paper form, quarterly or as otherwise directed by the Chief Public Health Officer; and (b) to the Minister (i) in an electronic form acceptable to the Minister, or (ii) in paper form, quarterly or as otherwise directed by the Minister. (EC529/14; 415/15; 520/17; 346/18; 926/22; 528/24; 420/26) 3. Immunization records (1) A member of a regulated health profession who immunizes a patient shall record the following information: (a) the patient’s name, date of birth, sex, address and provincial health number; (b) the name, dose, manufacturer and lot number of the immunizing agent; (c) the immunization route and site on the patient’s body; (d) the date of immunization; (e) the member’s name. Retention of record (2) The member shall retain a record created under subsection (1) for not less than 10 years from the date of the immunization and provide the record to the Chief Public Health Officer on request. (EC529/14; 415/15; 478/15; 520/17; 346/18; 926/22; 420/26) 4. Adverse event following immunization (AEFI) Where a member of a regulated health profession observes an adverse event following immunization, whether after immunizing or on treating the patient, the member shall report the adverse event to the Chief Public Health Officer as soon as possible but not later than 24 hours after observation. (EC529/14; 520/17; 926/22; 420/26) 5. Immunization registry may be established (1) The Chief Public Health Officer may establish and maintain, in the form of a computerized network and database, an immunization registry of information reported in accordance with these regulations. Purposes of immunization registry (2) The purposes of the immunization registry are (a) to provide authorized users with access to immunization records of patients to assist in patient care; (b) to provide for the monitoring of information respecting immunizations for the purpose of establishing and administering immunization programs; (c) to act as a repository of information for health planning, research and the evaluation of the beneficial and adverse effects of immunizing agents; and (d) to provide for the monitoring of immunization rates in the province. (EC520/17; 420/26) Page 4 Current to: April 11, 2026 t c Immunization Regulations Section 6 6. Application for access (1) The following persons may apply to the Chief Public Health Officer, in the form required by the Chief Public Health Officer, for access to the immunization registry: (a) any of the following members of a regulated health profession: (i) a licensed practical nurse, (ii) a medical practitioner, (iii) a midwife, (iv) a pharmacist or pharmacy technician, (v) a registered nurse or nurse practitioner; (b) a person employed to provide administrative support services to a medical practitioner, nurse practitioner or public health nurse. Access granted (2) On receipt of an application in accordance with subsection (1), the Chief Public Health Officer may grant the person access to the immunization registry if (a) in the case of an applicant referred to in clause (1)(a), the person is (i) engaged or employed in providing health care in the person’s professional capacity, and (ii) in good standing with the college governing the regulated health profession of which the person is a member; (b) in the case of an applicant referred to in clause (1)(b), the person requires access to the immunization registry for the purposes of the person’s employment. Register (3) The Chief Public Health Officer shall keep a register of authorized users granted access pursuant to this section. Requirements no longer met (4) An authorized user granted access to the immunization registry under this section shall cease to have access if the authorized user ceases to meet the applicable requirements under clause (2)(a) or (b). Suspension or revocation of access (5) The Chief Public Health Officer may suspend or revoke the access of an authorized user granted access pursuant to this section if the Chief Public Health Officer has reasonable grounds to believe that the authorized user (a) contravened subsection 9(3); or (b) facilitated access to the immunization registry by a person who is not an authorized user. Due process (6) Before suspending or revoking the access of an authorized user pursuant to subsection (5), the Chief Public Health Officer shall: (a) serve notice in writing of the Chief Public Health Officer’s intention to suspend or revoke the authorized user’s access, including reasons, on the authorized user and the authorized user’s employer or the operator of any health facility where the authorized user is engaged in the provision of health care, as the case may be; c t Current to: April 11, 2026 Page 5 Section 7 Immunization Regulations (b) give the authorized user an opportunity to make submissions orally or in writing within a specified time period respecting the proposed suspension or revocation; (c) consider the submissions of the authorized user, if any; and (d) serve notice in writing of the Chief Public Health Officer’s decision, including reasons, and the suspension or revocation, if applicable, on the authorized user and the authorized user’s employer or the operator of any health facility where the authorized user is engaged in the provision of health care, as the case may be. (EC520/17; 346/18; 926/22; 420/26) 7. User identification (1) The Chief Public Health Officer shall assign unique user identification to each authorized user. Record of access (2) The Chief Public Health Officer shall ensure that an electronic record of the following information is automatically created each time information is accessed in the immunization registry: (a) the user identification of the authorized user accessing the information; (b) the date and time the information is accessed; (c) a description of the information that the authorized user accesses. Retention of record (3) The Chief Public Health Officer shall ensure that an electronic record created pursuant to subsection (2) is retained for at least 10 years following the date of the access. (EC520/17) 8. Copy of information, patient (1) A patient may request, and an authorized user shall provide, a copy of information respecting the patient recorded in the immunization registry. Copy of access record, patient (2) A patient may request, and the Chief Public Health Officer shall provide, a copy of an electronic record created pursuant to subsection 7(2) in respect of access to information respecting the patient recorded in the immunization registry. (EC520/17) 9. Prohibition, access (1) No person shall access the immunization registry except (a) an authorized user, whose access has not been suspended or revoked; or (b) a person who is providing technical support in respect of the immunization registry. Prohibition, use or disclosure (2) No person other than an authorized user shall use or disclose information recorded in the immunization registry. Prohibition, authorized user (3) No authorized user, other than the Chief Public Health Officer, shall use or disclose information respecting a patient recorded in the immunization registry unless the use or disclosure is Page 6 Current to: April 11, 2026 t c Immunization Regulations Section 9 (a) authorized by the patient or the patient’s substitute decision-maker in accordance with subsection (6); or (b) necessary for the provision of health care to the patient. Use by Chief Public Health Officer (4) In addition to the circumstances described in clauses (3)(a) and (b), the Chief Public Health Officer may use information respecting a patient recorded in the immunization registry in the following circumstances: (a) the information is de-identified; (b) the use is for the purpose of (i) delivering, evaluating or monitoring an immunization program, (ii) health planning, research, and the evaluation of the beneficial and adverse effects of vaccines, (iii) monitoring immunization rates in the province, (iv) evaluating and monitoring the health and safety of the general public. Disclosure by Chief Public Health Officer (5) In addition to the circumstances described in clauses (3)(a) and (b), the Chief Public Health Officer may disclose information respecting a patient recorded in the immunization registry in the following circumstances: (a) the information is de-identified; (b) the disclosure is for the purpose of (i) delivering, evaluating or monitoring an immunization program, (ii) health planning, research, and evaluating the beneficial and adverse effects of vaccines, (iii) monitoring immunization rates in the province, (iv) evaluating and monitoring the health and safety of the general public, (v) complying with a summons, subpoena, warrant, order or similar requirement issued by a court, person or entity with jurisdiction to compel the production of personal health information, or (vi) complying with the rules of court concerning the production of evidence in a proceeding; (c) the disclosure is to (i) a public health authority established under an Act of the Parliament of Canada, another province or other jurisdiction, if the disclosure is for a public health purpose, or (ii) a professional regulatory body with statutory authority over persons practising a health profession, including for the purpose of an investigation by that body; (d) the disclosure is required by an enactment or an Act of the Parliament of Canada. Substitute decision-maker (6) For the purpose of clause (3)(a), where a patient is incapable of consenting, or of communicating that consent, to the use or disclosure of information respecting the patient recorded in the immunization registry, one of the following persons may, in descending order of priority, on the patient’s behalf and in the place of the patient, act as a substitute decision- maker for that patient by giving, not giving, withholding or withdrawing the consent, provided the person is capable of doing so: c t Current to: April 11, 2026 Page 7 Section 9 Immunization Regulations (a) a person who has been authorized, in writing, by the patient to provide consent; (b) the patient’s guardian; (c) the patient’s spouse; (d) the patient’s adult child; (e) the patient’s parent; (f) the patient’s adult sibling; (g) any other adult next of kin of the patient; (h) a person who is authorized under an enactment to practise a health profession in the province and is providing health care to the patient; (i) the Public Guardian; (j) where the patient is deceased, (i) the patient’s personal representative as defined in the Probate Act R.S.P.E.I. 1988, Cap. P-21, or (ii) the patient’s (A) spouse, (B) adult child, (C) parent, (D) sibling, or (E) any other adult next of kin. (EC520/17; 346/18) Page 8 Current to: April 11, 2026 t c